DECLARACIÓN DE CONFORMIDAD DE …€¦ · INMOVILIZADORES DE PACIENTE, CABEZA Y TRONCO, PARA USO...

Ministerio de Salud

Secretaría de Regulación y Gestión SanitariaA.N.M.A.T.

2018 - AÑO DEL CENTENARIO DE LAREFORMA UNIVERSITARIA

ANEXO II

DECLARACIÓN DE CONFORMIDAD DE MODIFICACIÓN – PM CLASE I- II

Número de revisión: 01

Fecha de Emisión de la Declaración revisión 00-Disposición Autorizante o su reválida:04/12/2017

Número de PM:

2202-10

Nombre Descriptivo del producto:

INMOVILIZADORES DE PACIENTE, CABEZA Y TRONCO, PARA USO EN RADIOTERAPIA

Código de identificación y nombre técnico UMDNS:

15726 – Camillas Radiológicas

Clase de Riesgo:Clase I

Marca de (los) producto(s) médico(s):

QFix

Modelos (en caso de clase II y equipos):

RT-4454MRI - Access Prone with MR CoilsRT-4521CSA - Prone Cranial Spinal Axis KitRT-4524LW - AccuFix Extra Tall Shoulder-Loc, Set of 2RT-4524LW-MRI - AccuFix Extra Long Shoulder-Loc, Set of 2 MRI versionRT-4524LW-SMRI - AccuFix Extra Tall Shoulder-Loc, Set of 2 CT compatible, MRI versionRT-4524LW-S - CT Version, Extra-Tall Shoulder-LocRT-4524PED - AccuFix Pediatric Shoulder-Loc, Set of 2RT-4524PED-MRI - AccuFix Pediatric Shoulder-Loc, Set of 2, CT compatible, MRI version

Página 1 de 17PM Número: 2202-10 Página 1 de 17

El presente documento electrónico ha sido firmado digitalmente en los términos de la Ley N° 25.506, el Decreto N° 2628/2002 y el Decreto N° 283/2003.-

RT-4524PEDXX-S - AccuFix Pediatric Shoulder-Loc, Set of 2 CT compatibleRT-4524XX - AccuFix Standard Shoulder-Loc, Set of 2RT-4524XX-MRI - Accufix Standard Shoulder-Loc, Set of 2 MRI versionRT-4524XX-S - AccuFix Standard Shoulder-Loc, Set of 2 CT compatibleRT-4524XX-SMRI - AccuFix Standard Shoulder-Loc, Set of 2 CT compatible, MRI versionRT-4525 - AccuFix Cantilever Board w Standard Shoulder-LocRT-4525KVL - kVue Accufix Cantilever Board, Featherline EditionRT-4525L - Accufix Cantilever Board, Featherline Edition.RT-4525LKV - kVue Accufix Cantilever Board, Featherline EditionRT-4525LMRI - Accufix Canti Board MRI CompatibleRT-4525LSPLIT - AccuFix Cantilever Board Split Frame Adapter BlackRT-4525MRI - Accufix MRI Cantilever BoardRT-4525MTSPLIT - MT Base head plate Split Frame Adapter, BlackRT-4525-REF - Accufix Cantilever Board - Refurbished,RT-4525P2BA - S-Loc Base -lower, pt lft sideRT-4525P8 - M1 Hold Down, 4pkRT-4525TILT - Tilt-Pro Tilting BaseRT-4525TILT-A - ProBoard Flat Carbon Fiber Head BoardRT-4525TILT-B - Upgrade Bracket Kit to RT-4525TILT-ART-4525TILTMRI - Tilt-Pro Tilting Base, MRI compatible versionRT-4525TILTMRI-A - Proboard Flat MRI HeadboardRT-4527 - AccuFix Cantilever Board Adapter - GenericRT-4529AX - Timo BaseplateRT-4529M - AccuFix Medium Disk Set, Set of 4RT-4529M1 - AccuFix Medium DiskRT-4529S - AccuFix Shim, 11 1/4"x7 1/8" 1/16"RT-4490BOS1 - Foam HeadrestRT-4543 - Quest Carbon Fiber Breast Board Includes Bottom StopperRT-4543MRI - Quest MR BreastboardRT-4543AA - Quest Breast Board Arm SupportRT-4543AH - Quest Breast Board Two-pin Hand Grip PostRT-4543AW - Quest Breast Board Wrist SupportRT-4543B - Quest Breast Board Meduim Disk Set to mount to Exact couch.RT-4543H2 - Quest Breast Board Bottom Stopper Assy Bottom Stopper and PlateRT-4543P - Breastboard Clocking Plate KITRT-4543PK1 - Quest Breast Board Package IRT-4543PK3 - Quest Breast Board Package IIRT-4543PK5 - Accufix QUEST Breast Board DELUXE Package IIIRT-4543PK5SOLID - Accufix QUEST Solid Breast Board DELUXE PackageRT-4543S - Quest Breast Board Silverman AdapterRT-4543SOLID - Quest Carbon Fiber Breast Board w solid panels.RT-4543WALL - Wall mount for Quest and AccuFix BoardsRT-4546-01 - Access Supine Breast DeviceRT-4544 - Access Prone Breast Treatment Device with headrests and hand gripsRT-4546-02 - Access Supine Breast and Lung Treatment DeviceRT-4544-03A - Access Prone ShimsRT-4544KV-IND - Vac-Q-Fix Indexer, Access 360RT-4546 - Access Supine Breast Treatment Device w/foam headrest and bottom stopperRT-4546L - Access Supine Accessory Ladder SetRT-4546AA - Access Arm SupportRT-4546AW - Access Wrist Cup



RT-4546MRI - Access Supine MR and Breast Treatment Device w/foam headrestandbottomstopperRT-4547P - QFix CF Curve Board w/ black painted surfaceRT-4549MRI - MR 5 point device8001656 - Head and Neck Chair Assembly8001907 - HN Chair BoS w/Bite Block Mount8002050 - Procure Chair Setup BoSRT-4545CV-17 - ClearVision Prone Breast Device 17.5cm highRT-4545CV-20 - ClearVision Prone Breast Device 20cm highRT-4545CV-FL - Access ClearVue Prone Breast Insert, FlatRT-4545CV-FM - Access ClearVue Prone Breast Insert, FlatRT-4545CV-FS - Access ClearVue Prone Breast Insert, FlatRT-4545CV-L - ClearVision Prone Breast Insert, Large Large, 30cm cutoutRT-4545CV-M - ClearVision Prone Breast Insert, Medium Medium, 25cm cutoutRT-4545CV-S - ClearVision Prone Breast Insert, Small Small, 20cm cutoutRT-4488-01 - SofTouch Couch Top Pad 0.6 cm x 50 cm x 100 cmRT-4488-02 - SofTouch Couch Top Pad 1.9 cm x 50 cm x 100 cmRT-4488-03 - SofTouch Couch Top Pad 0.6 cm x 50 cm x 180 cmRT-4488-04 - SofTouch Couch Top Pad 1.9 cm x 50 cm x 180 cmRT-4550GEC - QUANTUM CT Overlay, 262 cm long cradleRT-4550GEDLS - QUANTUM CT Overlay, 266 cm long cradleRT-4550GEH - QUANTUM CT Overlay, 219 cm long cradleRT-4550GEL - QUANTUM CT Overlay, 231 cm long cradleRT-4550GEP - QUANTUM CT OverlayRT-4550GER - QUANTUM CT Overlay, 207 cm long cradleRT-4550KVGEC - kVue CT Base, 262 cm long cradleRT-4550KVGEL - kVue CT Base, 231 cm long cradleRT-4550-KVGEP - kVue CT Base GE ProSpeed 207 cmRT-4550KVGEP - kVue CTRT-4550KVGER - kVue CT Base, 207 cm long cradleRT-4550KVPBR - KVue CT Base, 250cm long cradleRT-4550KVPTOF - kVue CT BaseRT-4550KVSS1 - kVue CT, 244cm long cradleRT-4550KVSS2 - kVue CT, 217cm long cradleRT-4550KVSS3 - kVue CT BaseRT-4550KVSS4 - kVue CT Siemens OverlayRT-4550KVSS5 - kVue CT Overlay - Siemens BiographRT-4550KVTAQ - KVue CT, 215cm long cradleRT-4550MLDR - Mouldroom CouchtopRT-4550PBR - QUANTUM CT Overlay, 250cm long cradleRT-4550PQ - QUANTUM CT, 239cm long cradleRT-4550SEA - Eagle RTP Pallet - SIEMENS Material #10531406RT-4550SS1 - QUANTUM CT Overlay, 244cm long cradleRT-4550SS2 - QUANTUM CT, 217cm long cradleRT-4550SS3 - Quantum CT, for 240cm long cradleRT-4550SS4 - Quantum Overlay - Siemens PHS1BRT-4550-SYMBIAT - Symbia Radiation Therapy PalletRT-4550TAQ - QUANTUM CT, 215cm long cradleRT-4550INSTALL - Professional installation of QUANTUM CT Overlay.RT-4550KVINSTALL - Profession installation of kVue CT OverlayRT-4525KV - kVue Accufix Cantilever Board Insert



RT-4535-01 - kVue POD InsertRT-4535KV - BoS kVue insertRT-4535KVBB - BoS Headframe kVue Insert, SRS ReadyRT-4536KV - kVue insert for use w BrainLAB 43405 Mask BaseRT-4544KV-09 - kVue Access 360 PackageRT-4544KV - kVue Access 360 Prone Breast Insert - PackageRT-4544KV-06 - Prone HeadrestRT-4544KVPKG - Access 360 kVue Package Access 360, kVue Baseframe, Backpanel, StdinsertRT-4547KV - kVue CURVE Board InsertRT-4549KV - kVue Pentafix InsertRT-4550KVPBRPM - kVue CT Phantom MountRT-4551-SRT-A1 - Adapter Kit to Quantum CouchTopRT-4551BAR-02 - Calypso Compatible Locating Bar, Exact IndexingRT-4551BAR-03 - QA Locating BarRT-4551BARMRI - Qfix MRI Locating BarRT-4551KV - kVue IGRT Couchtop Baseframe w Moving Stealth BeamRT-4551KV0 - kVue Back Panel with Exact compatible indexingRT-4551KV0-E - kVue Calypso Compatible EDGE Back PanelRT-4551KV0CL - Calypso Indexing Back Panel - OnlyRT-4551KV0-N - kVue Non-Indexing Back PanelRT-4551KVOTM-E - kVue Edge OnetouchRT-4551KV1 - kVue Standard Indexing InsertRT-4551KV1CL - Calypso Compatible ETR Couchtop kVue InsertRT-4551KVCL-V - kVue Calypso Compatible Couch Top Base Frame with Varian Exact IndexingRT-4551KV2 - kVue Short Indexing InsertRT-4551KV5 - kVue DoseMax Insert w Virtual IndexingRT-4551KV7CL - Precise Couchtop Insert Calypso CompatibleRT-4551KV7CLS - kVue Couchtop Insert - Calypso Compatible ZXT and TXTRT-4551KV8 - kVue Tip Extension Base InsertRT-4551KV9 - 192cm kVue InsertRT-4551KV10 - kVue Brachy InsertRT-4551KV12 - kVue Calypso Compatible Standard EDGE InsertRT-4551KV13 - 161 cm Standard InsertRT-4551KV14 - Siemens kVue Insert, CalypsoRT-4551KV15 - Calypso kVue, Elekta InsertRT-4551KV16 - kVue 161cm Couch Top Insert Without Virtual IndexingRT-4551KV17 - kVue Standard Couch Top Insert Without Virtual IndexingRT-4551KV18 - DoseMax Insert for SBRTRT-4551KVCL-M - kVue Couchtop Baseframe Calypso Compatible w Moving Support BeamsRT-4551KVE - kVue IGRT Couch Top Base FrameRT-4551KVP - kVue Pro Couch Top Base Frame Requires at least one insert to functionRT-4551KV-SRT - kVue Baseframe-SRT version w/648mm baseRT-4551KV-SRT-2 - kVue Baseframe - SRT version w 906mm baseRT-4551KV-SRT-2-ANT - SRT kVue Couchtop Baseframe for Anesthesia UnitRT-4551KV-SRT-3 - kVue Baseframe - SRTversion, 648mm base wo mounting holeRT-4551KV-SRT-4 - kVue Baseframe - Shaer proton couch versionRT-4551KV-SRT-5 - kVue Baseframe-SRT Version w/ Varian MountingRT-4551KV-SRT-6 - kVue Baseframe, SRT, 648mm Base, 2 CouplerRT-4551KV0CL-V - kVue Calypso Back Panel with Varian Exact IndexingRT-4551KV0-SRT - kVue Index Back Panel



RT-4551KVV - Varian kVue kitRT-4551KVV-SBRT - Qfix Varian SBRT PackageRT-4551KVV-SRS - Qfix Varian SRS PackageRT-4551-PROC - Quantum Carbon Fiber Couchtop 1550 mm longRT-4551SRV - Qfix Couchtop Service PanelRT-4552KV - kVue Portrait Head and Neck InsertRT-4558KV1 - kVue Stradivarius SBRT insertRT-4558KV2 - 38cm Variable Height BridgeRT-4558KV3 - 48cm Variable Height BridgeRT-4558KV4 - Compression PaddleRT-4558KV-PKG - kVue SBRT package Includes RT-4551KV, RT-4551KV0 RT-4558KV1RT-4544KV-01 - kVue Access 360 Couchtop Insert, Right BreastRT-4544KV-02 - kVue Access 360 Couchtop Insert, Left BreastRT-4544KV-03 - kVue Access 360 CT Riser SetRT-4544KV-03A - kVue Access 360 CT Riser Shims, 1 SetRT-4544KV-07 - Contour HeadrestRT-4551KVV-CL - kVue Calypso Varian KitRT-4551KVV-E - kVue Edge Varian KitRT-4588-01 - DoseMax Standalone DeviceRT-4600KV-01 - Encompass Head and Neck kVue InsertRT-4600-01 - Encompass Head and Neck Standalone DeviceRT-4600-01-MRI - Encompass Head and Neck MRI Standalone DeviceRT-B889KYCF - Encompass Intracranial Fibreplast Variable PerfRT-B889KYCF2 - Encompass Fibreplast Variable Perf Open ViewRT-4544-01 - Access Prone II Breast Treatment Device w/headrests + hand gripsRT-4544KV-11 - kVue Access 360 G2 Right InsertRT-4544KV-12 - kVue Access 360 G2 Left Insert8001904 - Quantum Couchtop, 2000mmRT-4551KV-01 - kVue One Couch TopRT-4551KV-03 - kVue One Proton Couch TopRT-4551KV11 - kVue Calypso Compatible Standard InsertRT-4517-4079VF15M - Vac-Q-Fix Cushion 40cm x 80cm, 15L FillRT-4517-12075F35M - Vac-Q-Fix Cushion 120cm x 75cm, 35L FillRT-4517100100TRAPF35M - Vac-Q-Fix Cushion, 100cm x100cm TRAP 35L fillRT-4464-02 - Qfix SofTouch Elite Belly Board System 8001643RT-4491-Q1 - Q1 IGRT Head Rest, Sub ART-4491-Q2 - Q2 IGRT Head Rest, Sub BRT-4491-Q3-2G - Q3 IGRT Customizable Head Rest, Sub B w/holeRT-4491-Q4-2G - Q4 IGRT Customizable Head Rest, Sub B with holeRT-4491R2 - Silverman Head Supports, Set of 6RT-4491R2-A - Silverman Head Supports, Size A Second Gen designRT-4491R2-B - Silverman Head Supports, Size B Second Gen designRT-4491R2-C - Silverman Head Supports, Size C Second Gen designRT-4491R2-D - Silverman Head Supports, Size D Second Gen designRT-4491R2-E - Silverman Head Supports, Size E Second Gen designRT-4491R2-F - Silverman Head Supports, Size F Second Gen designRT-4491R-M - Silverman Head Support, extra low profileRT-4491R-M2 - Silverman Head Support, extra low profile, M2 versionRT-4494 - Gel Doughnut Headrest, LargeRT-4494-P - Gel Doughnut Headrest, SmallRT-4517-0003 - 3 Chamber Vacuum Cushion



RT-4517-0002 - 2 Chamber Vacuum CushionRT-4517-100100F30 - Vac-Q-Fix Cushion, 100cm x 100cm, 30L fill SingleStep ValveRT-4517-100100F30M - Vac-Q-Fix Cushion, 100cm x 100cm, 30L fill Economy ValveRT-4517-100100F40 - Vac-Q-Fix Cushion, 100cm x 100cm, 40L fill SingleStep ValveRT-4517-100100F40M - Vac-Q-Fix Cushion, 100cm x 100cm, 40L fill Economy ValveRT-4517100100TRAPF35 - Vac-Q-Fix Cushion, 100cmx100cmTRAP 35L fill Single Step ValveRT-4517-100130PENF45 - Vac-Q-Fix Cushion, PENT, 45L fill Single Step ValveRT-4517-100150F70 - Vac-Q-Fix Cushion, 100cm x 150cm 70L fill Single Step ValveRT-4517-100150F70B - Vac-Q-Fix Cushion, 100cm x 150cm, 70L fillRT-4517-100150F70M - Vac-Q-Fix Cushion, 100cm x 150cm, 70L fill Economy ValveRT-4517-100220F120 - Vac-Q-Fix Cushion, 100cm x 220cm, 120L fill Single Step ValveRT-4517-1002200F120M - Vac-Q-Fix 100x220cm,120LRT-4517-10070F30 - Vac-Q-Fix Cushion, 100cm x 70cm, 30L fill Single Step ValveRT-4517-10070F30M - Vac-Q-Fix Cushion, 100cm x 70cm, 30L fill Economy ValveRT-4517-10070F35 - Vac-Q-Fix Cushion, NylonRT-4517-10070F35M - Vac-Q-Fix Cushion, 100cm x70cm, 35 liter fill Economy ValveRT-4517-10070F40 - Vac-Q-Fix Cushion, 100cm x 70cm, 40L fill SingleStep ValveRT-4517-10070F40M - Vac-Q-Fix Cushion, 100cm x 70cm, 40L fill Economy ValveRT-4517-10070F43 - Vac-Q-Fix Cushion, 100cm x 70cm, 43L fill SingleStep ValveRT-4517-12070F40 - 120x70cm,40L Vacuum CushionRT-4517-12075F35 - 120x75cm, 35L Vacuum CushionRT-4517-230120T80F90 -VacQFixCush120/80cm230cm90LfillSingleStepValve120cmtaperedto80cmRT-4517-230120T80F90M - Vac-Q-Fix 120/20x230cm,90LRT-4517-2535F1.5 - Vac-Q-Fix Cushion, 25cm x 35cm, 1.5L fill SingleStep ValveRT-4517-2535F2.0 - Vac-Q-Fix Cushion, 25cm x 35cm, 2.0L fill SingleStep ValveRT-4517-2535F1.5M - Vac-Q-Fix Cushion, 25cm x 35cm, 1.5L FillRT-4517-4079VF15 - Vac-Q-Fix Cushion, 40cm x 79cm, 15L fill SingleStep Valve w/Bridge ClipRT-4517-4080F15 - Vac-Q-Fix Cushion, 40cm x 80cm, 15L fill SingleStep ValveRT-4517-4080F15M - Vac-Q-Fix Cushion, 40cm x 80cm, 15L fill Economy ValveRT-4517-5070F15 - Vac-Q-Fix Cushion, 50cm x 70cm, 15L fill SingleStep ValveRT-4517-5070F15M - Vac-Q-Fix Cushion, 50cm x 70cm, 15L fill Economy ValveRT-4517-70150F60 - Vac-Q-Fix Cushion, 70cm x 150cm, 60L fill SingleStep ValveRT-4517-70150F60M - Vac-Q-Fix Cushion 70cm x 150cm 60L Fill for upperRT-4517-70230F65F - Vac Q-Fix Cushion 70 x 230 , 65L fill SingleStep Valve and Framed EdgeRT-4517-7070F20 - Vac-Q-Fix Cushion, 70cm x 70cm, 20L fill SingleStep ValveRT-4517-7070F20M - Vac-Q-Fix Cushion, 70cm x 70cm, 20L fill Economy ValveRT-4517-80150F65 - Vac-Q-Fix Cushion, 150cm x 80cm, 65L fill SingleStep ValveRT-4517-80150F65M - Vac-Q-Fix Cushion, 150cm x 80cm, 65L fill Economy ValveRT-4517-IND01 - Vac-Q-Fix IndexerRT-4517-MTVCAP - Vac-Q-Fix cushion Economy (MT) Valve CapRT-4517-PB2 - Vac-Q-Fix Cushion, Prone Breast CushionRT-4517-0002 - Vac-Q-Fix Cushion 160 cm x 120/80cm, 2 ChambersRT-4517-PLATE1 - Vac-Q-Fix Primary Indexing PlateRT-4517-PLATE2 - Vac-Q-Fix Secondary Indexing Plate w two slotsRT-4517-Rack - Vac-Q-Fix Mobile Storage RackRT-4517-Rack2 - Vac-Q-Fix Mobile Storage Rack, double barRT-4517-T6565F7 - Vac-Q-Fix Cushion, 65cm x 65cm, T-Shaped , 7L fill SingleStep ValveRT-4517-T6565F7M - Vac-Q-Fix Cushion, 65cm x 65cm, T-Shaped, 7L fill Economy MT ValveRT-4517-T7993F20 - Vac-Q-Fix Cushion 79cm x 93cm, 20L fill SingleStep ValveRT-4517-T7993F20M - Vac-Q-Fix Cushion 79cm x 93cm, 20L fill Economy Valve



RT-4517100130PENF45 - Vac-Q-Fix Cushion, 100cm x 130cm, PEN, 45L fillRT-4517100130PENF45M - Vac-Q-Fix Cushion, 100cm x 130cm, PEN, 45L fillRT-4517-PB1 - Prone Breast Cushion 1RT-4517-PB2 - Prone Breast Cushion 2RT-4535BOS - BoS Headframe 2nd Generation Stand Alone UnitRT-4535BOSBB - BoS Headframe, Standalone, 28mm SRS ReadyRT-4535BOSMRI - AccuFix BoS Headframe MRI Compatible 2nd Generation Stand Alone UnitRT-4535BOSV - AccuFix Vertex BoS HeadframeRT-4535BOSVBB - BoS Headframe, Shaer Couch, SRS ReadyRT-4535KV01 - BoS kVue Insert 121cmRT-4535KV02 - kVue BoS Insert Without Virtual IndexingRT-4535KV03 - kVue BoS Couch Top Insert 24” Cantilevered Without Virtual IndexingRT-4547 - Qfix Carbon Fiber Curve BoardRT-4547MRI - Curve Board, MRI Compatible VersionRT-4548 - Flat Polycarbonate Head BoardRT-4551BAR - Qfix Locating Bar, EXACT Compatible CouchtopsRT-4551BAR-01 - Sliding Locating BarRT-4551BARCL1 - Calypso Compatible Locating BarRT-4551BARCL3 - Calypso Non-Conductive Locating BarRT-4551CART - kVue Insert Storage CartRT-4552-01 - kVue Portrait with DoseMax GridRT-4552-V02 - Portrait Device IGRT Couch Top Varian PackageRT-4552-V01 - Portrait Device kVue Couch Top Varian PackageRT-4600-V02 - Encompass Device IGRT Couch Top Varian PackageRT-4600-V01 - Encompass Device kVue Couch Top Varian PackageRT-4552-V03 - Portrait Device VisionRT 3 Deg. of FreedomRT-4552KV-01 - kVue Portrait Proton Head and Neck InsertRT-4558-1 - Stradivarius SBRT Overlay No AccessoriesRT-4558CB01 - Stradivarius Compression Belt Two belt sizes (115 cm / 150 cm)RT-4558MRI - Stradivarius SBRT MRI OverlayRT-4552 - Portrait Head and Neck DeviceRT-4552MRI - Portrait MR Head and Neck DeviceRT-4552VI - Portrait Head & Neck Device w/Virtual IndexingRT-4556 - AccuFix SRS SystemRT-4558-B1 - kVue SBRT Bridge - smallRT-4558-B2 - kVue SBRT Bridge - LargeRT-4558KV4-01 - Compression PaddleRT-4464-1 - SofTouch Belly Board patient positioning systemRT-4517-0003M - VacQfix Cushions 230cm x 120/80cm 3 ChamberRT-4517-100100TRAPF35 - VacQfix Cushion, 100cm x 100cm, TRAP 35L fillRT-4517-100220F120M - VacQfix Cushion, 100cm x 220cm, 120L fillRT-4517-70120F40 - VacQfix Cushion, 120xm x 70cm, 40L Fill Gen.IIRT-4517-PB1M - VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support8002040 - Aquaplast RT Hd Only S-Frame, Std Nose 3.2mmRT-1597B - Aquaplast RT Cosmas Cup, Size B 2" (5cm) wide x 8-1/2" (22cm) long, 2.4mmRT-1597C - Aquaplast RT Cosmas Cup, Size C 3" (8cm) wide x 10" (25cm) long, 2.4mmRT-1597D - Aquaplast RT Cosmas Cup, Size D 4" (10cm) wide x 11" (28cm) long, 2.4mmRT-1597E - Aquaplast RT Cosmas Cup, Size E 6" (15cm) wide x 12" (30cm) long, 2.4mmRT-1619 - Thermoplastic Ivory, 1.6mm, 9" X 10", SolidRT-1622 - Aquaplast RT Sheet, 18" x 24", 1.6mm, SolidRT-1652LS - Aquaplast RT Sheet, 18" x 24", 1.6mm, LS Perf



RT-1679 - Aquaplast U-Frame, Std, 1.6mm 1.6mm 40%RT-1679L - Aquaplast U-Frame, Lng , 1.6mm 1.6mm 40%RT-1679S - Aquaplast Slim U-Frame, Std, 1.6mm 1.6mm 40%RT-1679SD - Aquaplast Hd Only S-Frame, Std, 1.6mm 1.6mm 40%RT-1679SL - Aquaplast RT Disposable Slimline U-frame 1.6mm Perforated, LongRT-1679SX - Aquaplast Slim U-Frame, Ext, 1.6mm 1.6mm 40%RT-1682 - Aquaplast RT Sheet, 1.6mm, 18" x 24" sheet PerfRT-1682ESD - Aquaplast RT Hd+Shldr CURVE S-Frame, 1.6mmRT-1682SD - Aquaplast Hd+Shldr S-Frame, 1.6mm 1.6mm 40%RT-1721P - Aquaplast RT Sheet, 2.4mm, Pre-punched 17-13/16" x 21-15/16"RT-1722 - Aquaplast RT Sheet, 18" x 24", 2.4mm, SolidRT-1722P18 - Aquaplast RT Sheet, 2.4mm, 18" x 24", Solid pre-punched on 18" sideRT-1722P24 - Aquaplast RT Sheet, 2.4mm, 18" x 24", Solid pre-punched on 24" sideRT-1724 - Aquaplast RT Sheet, 2.4mm, 24" x 36", SolidRT-1776KSDGXF - Fibreplast Splt Hd Only S-Frame, Ext. Face, 2.4mmRT-1776KSGLF - Assure Open View U-frames 2.4 mm LongRT-1776KSGXF - Fibreplast Open View Slim Split-Frame U-Frame Ext,RT-1776KSXF - Fibreplast Slim U-Frame, Ext Face, 2.4mm 2.4mm 20% w/M1 Open Face CutoutRT-1776KYSDGXF - Fibreplast Open View Splt Hd Only S-Frame VariableRT-1782KYSDF - Fibreplast Open View Hd +Shldr 2.4mm Variable PerfRT-1778 - Aquaplast RT Sheet, 18" x 24", 2.4mm 2.4mm 20%RT-1778KSDF - Fibreplast Open View Hd +Shldr 2.4mm Micro PerfRT-1778KFORF3 - Assure Open View Fibreplast 3-Point MaskRT-1778KORF3 - Fibreplast Orfit 3-Point, Std, 2.4mm 2.4mm 20%RT-1778KFORF5 - Assure Open View Fibreplast 5 Point MaskRT-1778KORF5 - Fibreplast Orfit 5-Point, 2.4mm 2.4mm 20%RT-1778KPR3 - Fibreplast PR 3-Point, Std, 2.4mm 2.4mm 20%RT-1778KPR4 - Fibreplast 4-Point Mask, 2.4 mm, 20% perforatedRT-1778KPR5 - Fibreplast PR 5-Point, 2.4mmRT-1778KPR3D - Fibreplast PR 3-Point, Std, 2.4mm Locks 2.4mm 20% w/ D-LocksRT-1778KPR4D - Fibreplast 4-Point Mask with disposable lockers 2.4 mm, 20% perforatedRT-1778KPR5D - Fibreplast PR 5-Point, 2.4mm Locks 2.4mm 20% w/ D-LocksRT-1778ORF3 - Aquaplast Orfit 3-Point, Std, 2.4mm 2.4mm 20%RT-1778ORF4 - Aquaplast Orfit 4-Point, 2.4mm 2.4mm 20%RT-1778ORF5 - Aquaplast Orfit 5-Point, 2.4mm 2.4mm 20%RT-1778PR2 - Aquaplast PR 2-Point, 2.4mm 2.4mm 20%RT-1778PR2D - Aquaplast PR 2-Point, 2.4mm Locks 2.4mm 20% w/ D-LocksRT-1778PR3 - Aquaplast PR 3-Point, Std, 2.4mm 2.4mm 20%RT-1778PR4 - Aquaplast PR 4-Point, 2.4mm 2.4mm 20%RT-1778PR4D - Aquaplast PR 4-Point, 2.4mm Locks 2.4mm 20% w/ D-LocksRT-1778PR5 - Aquaplast PR 5-Point, 2.4mm 2.4mm 20%RT-1778PR5D - Aquaplast PR 5-Point, 2.4mm Locks 2.4mm 20% w/ D-LocksRT-1778S - Aquaplast RT Sheet, 9" x 18", 2.4mm Perf, pre-punch 9" sideRT-1779 - Aquaplast U-Frame, Std, 2.4mm 2.4mm 40%RT-1779ESD - Aquaplast RT Hd Only CURVE S-Frame, Std, 2.4mmRT-1779ESDL - Aquaplast RT Hd Only CURVE S-Frame, Lng, 2.4mmRT-1779ESDX - Aquaplast RT Hd Only CURVE S-Frame, Ext, 2.4mmRT-1779KESD - Fibreplast Hd Only CURVE S-Frame, Std, 2.4mmRT-1779KESDL - Fibreplast Hd Only CURVE S-Frame, Lng, 2.4mmRT-1779KESDX - Fibreplast Hd Only CURVE S-Frame, Ext, 2.4mmRT-1779KR - Fibreplast Reloadable Hd Only S-Frame, 2.4mm 2.4mm 40%



RT-1779KS - Fibreplast Slim U-Frame, Std, 2.4mm 2.4mm 40%RT-1779KSD - Fibreplast Hd Only S-Frame, Std, 2.4mm 2.4mm 40%RT-1779KSDL - Fibreplast Hd Only S-Frame, Lng , 2.4mm 2.4mm 40%RT-1779KSD-S3 - Fibreplast Splt Hd Only S-Frame Gap, 2.4mm 2.4mm 40%RT-1779KSDX - Fibreplast Hd Only S-Frame, Ext , 2.4mm 2.4mm 40%RT-1779KSL - Fibreplast Slim U-Frame, Lng , 2.4mm 2.4mm 40%RT-1779KS-S3 - Fibreplast Splt Slim U-Frame Gap, Std, 2.4mm 2.4mm 40%RT-1779KSX - Fibreplast Slim U-Frame, Ext , 2.4mm 2.4mm 40%RT-1779L - Aquaplast U-Frame, Lng , 2.4mm 2.4mm 40%RT-1779O - Aquaplast Org U-Frame, Std, 2.4mm 2.4mm 40%RT-1779R - Aquaplast Reloadable Hd Only S-Frame, 2.4mm 2.4mm 40%RT-1779S - Aquaplast Slim U-Frame, Std, 2.4mm 2.4mm 40%RT-1779SD - Aquaplast Hd Only S-Frame, Std, 2.4mm 2.4mm 40%RT-1779SDL - Aquaplast Hd Only S-Frame, Lng , 2.4mm 2.4mm 40%RT-1779SDS3 - AquaplastRTDisposableHeadOnlySframe,splitframe, 2.4mm, perforated8cmgapRT-1779SDX - Aquaplast Hd Only S-Frame, Ext , 2.4mm 2.4mm 40%RT-1779SL - Aquaplast Slim U-Frame, Lng , 2.4mm 2.4mm 40%RT-1779SO - Aquaplast Slim Org U-Frame, Std, 2.4mm 2.4mm 40%RT-1779S-S3 - Aquaplast Splt Slim U-Frame Gap, Std, 2.4mm 2.4mm 40%RT-1779SX - Aquaplast Slim U-Frame, Ext , 2.4mm 2.4mm 40%RT-1779SXO - Aquaplast Slim Org U-Frame, Ext , 2.4mm 2.4mm 40%RT-1779X - Aquaplast U-Frame, Ext , 2.4mm 2.4mm 40%RT-1781P - Aquaplast RT Sheet, 9" x 10", 2.4mm, Perf pre-punchedRT-1782 - Aquaplast RT Sheet, 18" x 24", 2.4mm, PerfRT-1782ESD - Aquaplast RT Hd+Shldr CURVE S-Frame, 2.4mmRT-1782KESD - Fibreplast Hd+Shldr CURVE S-Frame 2.4mmRT-1782KORF3 - Fibreplast Orfit 3-Point, Std, 2.4mm 2.4mm 40%RT-1782KORF5 - Fibreplast Orfit 5-Point, 2.4mm 2.4mm 40%RT-1782KPR3 - Fibreplast PR 3-Point, Std, 2.4mm 2.4mm 40%RT-1782KPR3D - Fibreplast PR 3-Point, Std, 2.4mm Locks 2.4mm 40% w/ D-LocksRT-1782KPR4 - Fibreplast PR 4-Point, 2.4mm 2.4mm 40%RT-1782KPR4D - Fibreplast 4-Point Mask with disposable lockers 2.4 mm, 40% perforatedRT-1782KPR5 - Fibreplast PR 5-Point, 2.4mm 2.4mm 40%RT-1782KPR5D - Fibreplast PR 5-Point, 2.4mm Locks 2.4mm 40% w/ D-LocksRT-1782KS - Fibreplast Reloadable Hd+Shldr S-Frame, 2.4mm 2.4mm 40%RT-1782KSD - Fibreplast Hd+Shldr S-Frame, 2.4mm 2.4mm 40%RT-1782ORF3 - Aquaplast Orfit 3-Point, Std, 2.4mm 2.4mm 40%RT-1782ORF4 - Aquaplast Orfit 4-Point, 2.4mm 2.4mm 40%RT-1782ORF5 - Aquaplast Orfit 5-Point, 2.4mm 2.4mm 40%RT-1782PR2D - Aquaplast PR 2-Point, 2.4mm Locks 2.4mm 40% w/ D-LocksRT-1782PR3 - Aquaplast PR 3-Point, Std, 2.4mm 2.4mm 40%RT-1782PR3D - Aquaplast PR 3-Point, Std, 2.4mm Locks 2.4mm 40% w/ D-LocksRT-1782PR4 - Aquaplast PR 4-Point, 2.4mm 2.4mm 40%RT-1782PR4D - Fibreplast 4-Point Mask with disposable lockers 2.4 mm, 20% perforatedRT-1782PR5 - Aquaplast PR 5-Point, 2.4mm 2.4mm 40%RT-1782PR5D - Aquaplast PR 5-Point, 2.4mm Locks 2.4mm 40% w/ D-LocksRT-1782S - Aquaplast Reloadable Hd+Shldr S-Frame, 2.4mm 2.4mm 40%RT-1782SD - Aquaplast Hd+Shldr S-Frame, 2.4mm 2.4mm 40%RT-1782KSDEGF - Assure Open View Portrait Head and Shoulder 2.4 mm (CURVE)RT-1782KSDGF - Assure Open View Portrait Head and Shoulder 2.4 mm (Portrait)RT-1776KSDGLF - Assure Open View S-frames 2.4 mm Long



RT-1783P - Aquaplast RT Sheet, 12" x 18", 2.4mm, Perf pre-punched on 12" side for breastRT-1783P3 - Aquaplast RT Sheet, 12" x 18", 2.4mm, Perf pre-punched on 12" sideRT-1784 - Aquaplast RT Sheet, 24" x 36", 2.4mm, PerfRT-1784K - Fibreplast Sheet, 24" x 36", 2.4mm, PerfRT-1788 - Aquaplast RT Sheet, 9" x 12", 2.4mm, PerforatedRT-1788P - Aquaplast RT Sheet, 9" x 12", 2.4mm, Perf pre-punchedRT-1800S - Aquaplast RT Slim U-Frame, Std, 3.2mm 3.2mm SolidRT-1804 - Aquaplast RT Sheet, 24" x 36", 3.2mm, Solid, XSRT-1819KS - Fibreplast Slim U-Frame, Std Nose, 3.2mm 3.2mm SolidRT-1819KSX - Fibreplast Slim U-Frame, Ext Nose, 3.2mm 3.2mm SolidRT-1822 - Aquaplast RT Sheet, 18" x 24", 3.2mm, SolidRT-1822K - Fibreplast Sheet, 18" x 24", 3.2mm, SolidRT-1824 - Aquaplast RT Sheet, 24" x 36", 3.2mm, SolidRT-1838 - Aquaplast RT Solid Strips, 1.5" x 18", 3.2mm Pkg. of 16RT-1876KSDGLF - Fibreplast Spt Hd Only S-Frame, Lng. Face, 3.2mmRT-1876KYSDGLF - Fibreplast Open View Split S-Frame 3.2mmRT-1876KSDGXF - Assure Open View S-frames 3.2 mm ExtendedRT-1876KFORF3 - Assure Open View Fibreplast 3 Point MaskRT-1876KSDGL - Fibre Splt. Hd Only S, w/out openfaceRT-1876KSGLF - Fibreplast Open View Slim Split Frame U-Frame LngRT-1876KSGXF - Assure Open View U-frames 3.2 mm ExtendedRT-1876KFORF5 - Assure Open View Fibreplast 5 Point MaskRT-1878KSDF - Fibreplast Open View Hd + Shld 3.2mm Micro PerfRT-1878BOS-D2L - Aquaplast 38cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 20%RT-1878BOS-D2LS - Aquaplast 31cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 20%RT-1878BOS-D2LVS - Aquaplast 26cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 20%RT-1878BOS-E2L - Aquaplast 48cm Conture Hd+Shldr BoS Flap, 3.2mm 3.2mm 20%RT-1878BOS-E2LS - Aquaplast 43cm Conture Sm Hd+Shlder Bos Flap,3.2mm 3.2mm 20%RT-1878K - Fibreplast Sheet 18" x 24" 3.2mm 20%RT-1878KBOS-D2L - Fibreplast 38cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 20%RT-1878KBOS-D2LS - Fibreplast 31cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 20%RT-1878KBOS-D2LVS - Fibreplast 26cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 20%RT-1878KBOS-E2L - Fibreplast 48cm Conture Hd+Shldr BoS Flap, 3.2mm 3.2mm 20%RT-1878KBOS-E2LS - Fibreplast 43cm Conture Sm Hd+Shlder BosFlap,3.2mm 3.2mm 20%RT-1878S - Aquaplast RT MT Breast, 3.2mm 3.2mm 20%RT-1882 - Aquaplast RT Sheet, 18" x 24", 3.2mm Perf, LSRT-1882BOS-D - Aquaplast 38cm Conture Hd+Neck BoS, 3.2mm 3.2mm 40% LSRT-1882BOS-DS - Aquaplast 31cm Conture Hd+Neck BoS, 3.2mm 3.2mm 40% LS PediatricRT-1882BOS-DVS - Aquaplast 26cm Conture Hd+Neck BoS Flap, 3.2mm 3.2mm 40%LSSmallPediatricRT-1882BOS-E - Aquaplast 48cm Conture Hd+Shldr BoS, 3.2mm 3.2mm 40% LSRT-1882BOS-ES - Aquaplast 43cm Conture Hd+Shldr BoS, 3.2mm 3.2mm 40% LSRT-1882ESD - Aquaplast RT Hd+Shldr CURVE S-Frame, 3.2mmRT-1882K - Fibreplast Sheet, 18" x 24". 3.2mm, PerfRT-1882KBOS-D - Fibreplast 38cm Conture Hd+Neck BoS Flap, 3.2mm Head and Neck mask.RT-1882KBOS-DS - Fibreplast 31cm Conture Hd+Neck BoS Flap, 3.2mm PediatricRT-1882KBOS-DVS - Fibreplast 26cm Conture Hd+Neck BoS Flap, 3.2mm Small PediatricRT-1882KBOS-E - Fibreplast 48cm Conture HD+Neck BoS Flap, 3.2mm Head and ShouldersRT-1882KBOS-ES - Fibreplast 43cm Conture HD+Neck BoS Flap, 3.2mm Head and ShouldersRT-1882KP - Fibreplast MT 3-Point Pelvis, 3.2mm 3.2mm 40%RT-1882KSDEGF - Assure Open View Portrait Head and Shoulder 3.2 mm (CURVE)



RT-1882KSDGF - Assure Open View Portrait Head and Shoulder 3.2 mm (Portrait)RT-1882ORF3 - Aquaplast Orfit 3-Point, Std, 3.2mm 3.2mm 40% LSRT-1882S - Aquaplast Reloadable Hd+Shldr S-Frame, 3.2mm 3.2mm 40% LSRT-1882SD - Aquaplast Hd+Shldr S-Frame, 3.2mm 3.2mm 40% LSRT-1883P - Aquaplast RT Sheet, 12" x 18", 3.2mm, Perf LS, pre-punchedRT-1883P3 - Aquaplast RT Sheet, 12" x 18", 3.2mm, Perf, pre-punched w 3 holes 12" sideRT-1889 - Aquaplast U-Frame, Std, 3.2mm 3.2mm 40%RT-1889-41130 - BrainLAB mask set 41130. Only sold to BrainLABRT-1889ESD - Aquaplast RT Hd Only CURVE S-Frame, Std, 3.2mmRT-1889ESDL - Aquaplast RT Hd Only CURVE S-Frame, Lng, 3.2mmRT-1889ESDX - Aquaplast RT Hd Only CURVE S-Frame, Ext, 3.2mmRT-1889KESD - Fibreplast Hd Only CURVE S-Frame, Std, 3.2mmRT-1889KESDL - Fibreplast Hd Only CURVE S-Frame, Lng, 3.2mmRT-1889KESDX - Fibreplast Hd Only CURVE S-Frame, Ext, 3.2mmRT-1889KS - Fibreplast Slim U-Frame, Std, 3.2mm 3.2mm 40% Solid EdgeRT-1889KSD - Fibreplast Hd Only S-Frame, Std, 3.2mm 3.2mm 40%RT-1889KSDL - Fibreplast Hd Only S-Frame, Lng , 3.2mm 3.2mm 40%RT-1889KSD-S3 - Fibreplast Splt Hd Only S-Frame Gap, 3.2mm 3.2mm 40%RT-1889KSDX - Fibreplast Hd Only S-Frame, Ext , 3.2mm 3.2mm 40%RT-1889KSL - Fibreplast Slim U-Frame, Lng , 3.2mm 3.2mm 40%RT-1889KSO - Fibreplast Slim Org U-Frame, Std, 3.2mm 3.2mm 40% Solid EdgeRT-1889KS-S3 - Fibreplast Splt Slim U-Frame Gap, Std, 3.2mm 3.2mm 40%RT-1889KSX - Fibreplast Slim U-Frame, Ext , 3.2mm 3.2mm 40%RT-1889KSXO - Fibreplast Slim Org U-Frame, Ext , 3.2mm 3.2mm 40%RT-1889KYESD - Fibreplast VP Hd Only CURVE S-Frame, Std. 3.2mmRT-1889KYS - Fibreplast VP, Slim U-Frame, Std. 3.2mm 3.2mm Variable PerfRT-1889KYSD - Fibreplast VP Hd Only S-Frame, Std. 3.2mm 3.2mm Variable PerfRT-1889KSYGLF - Fibreplast Open View Slim Split-Frame U-Frame Lng.RT-1889L - Aquaplast U-Frame, Lng , 3.2mm 3.2mm 40%RT-1889O - Aquaplast Org U-Frame, Std, 3.2mm 3.2mm 40%RT-1889SD - Aquaplast Hd Only S-Frame, Std, 3.2mm 3.2mm 40%RT-1889SDL - Aquaplast Hd Only S-Frame, Lng , 3.2mm 3.2mm 40%RT-1889SD-S3 - Aquaplast Splt Hd Only S-Frame Gap, 3.2mm 3.2mm 40%RT-1889SDX - Aquaplast Hd Only S-Frame, Ext , 3.2mm 3.2mm 40%RT-1889SL - Aquaplast Slim U-Frame, Lng , 3.2mm 3.2mm 40%RT-1889SLO - Aquaplast Slim Org U-Frame, Lng , 3.2mm 3.2mm 40%RT-1889SL-S3 - Aquaplast Splt Slim U-Frame Gap, Lng, 3.2mm 3.2mm 40%RT-1889SO - Aquaplast Slim Org U-Frame, Std, 3.2mm 3.2mm 40% Solid EdgeRT-1889S-S3 - Aquaplast Splt Slim U-Frame Gap, Std, 3.2mm 3.2mm 40%RT-1889S-S3O - Aquaplast Splt Slim Org U-Frame Gap, Std, 3.2mm 3.2mm 40%RT-1889SX - Aquaplast Slim U-Frame, Ext , 3.2mm 3.2mm 40%RT-1889SXO - Aquaplast Slim Org U-Frame, Ext , 3.2mm 3.2mm 40%RT-1889SX-S3 - Aquaplast Splt Slim U-Frame Gap, Ext, 3.2mm 3.2mm 40%RT-1889SX-S3O - Aquaplast Splt Slim Org U-Frame Gap, Ext, 3.2mm 3.2mm 40%RT-1889X - Aquaplast U-Frame, Ext , 3.2mm 3.2mm 40%RT-1889XO - Aquaplast Org U-Frame, Ext , 3.2mm 3.2mm 40%RT-1889YS - Aquaplast RT VP, Slim U-Frame, Std. 3.2mm 3.2mm Variable PerfRT-1889YESD - Aquaplast RT VP Hd Only Curve S-Frame, Std, 3.2mmRT-1889YSD - Aquaplast RT VP Hd Only S-Frame, Std. 3.2mm 3.2mm Variable PerfRT-1891P - Aquaplast RT Sheet, 9" x 10", 3.2mm, Perf pre-punched for U-FrameRT-1892 - Aquaplast RT Sheet, 18" x 24", 3.2mm, Perf



RT-1892KYSDF - Fibreplast Open View Hd + Shdr 3.2mm Variable PerfRT-1892ESD - Aquaplast RT Hd+Shldr CURVE S-Frame, 3.2mmRT-1892K - Fibreplast Sheet, 18" x 24", 3.2mm, PerfRT-1892KBOS-A2L - Fibreplast BoS, Ext Lock, 3.2mm 3.2mm 40%RT-1892KBOS-C - Fibreplast 2nd Gen BoS, 3.2mm 3.2mm 40%RT-1892KESD - Fibreplast Hd+Shldr CURVE S-Frame, 3.2mmRT-1892KSD - Fibreplast Hd+Shldr S-Frame, 3.2mm 3.2mm 40%RT-1892KSD-S - Fibreplast Hd+shldr Split S Frame, 3.2mm, Perf , No GapRT-1892KYESD - Fibreplast VP HD+Shldr CURVE S-Frame, 3.2mmRT-1892KYSD - Fibreplast VP HD+Shldr S-Frame, 3.2mm 3.2mm Variable PerfRT-1892SD - Aquaplast Hd+Shldr S-Frame, 3.2mm 3.2mm 40%RT-1892YESD - Aquaplast RT VP Hd+Shldr CURVE S-Frame, 3.2mmRT-1892YSD - Aquaplast RT VP Hd+Shldr S-Frame, 3.2mm 3.2mm Variable PerfRT-1896 - Aquaplast RT Sheet, 24" x 36", 3.2mm, PerfRT-1896K - Fibreplast Sheet, 24" x 36", 3.2mm, PerfRT-1908-4 - Aquaplast RT Custom Bolus, 4.8mm, 7cm x 22cmRT-1910-4 - Aquaplast RT Custom Bolus, 4.8mm, 20cm x 23cmRT-1913-2 - Aquaplast RT Bolus, 2.4mm, 30cm x 30cm SolidRT-1913-3 - Aquaplast RT Bolus, 3.2mm, 30cm x 30cm SolidRT-1913-4 - Aquaplast RT Custom Bolus, 4.8mm, 30cm x 30cmRT-1914 - Aquaplast Sheet, 4.8mm Solid IB, 24"x36"RT-1914-3 - Aquaplast RT Bolus, 3.2mm, 30cm x 35cm SolidRT-1921-4 - Aquaplast RT Custom Bolus, 4.8mm, 5cm x 6cmRT-1922 - Aquaplast RT Custom Bolus, 4.8mm x 45cm x 60cmRT-1924 - Aquaplast RT Sheet, 24" x 36", 4.8mm, SolidRT-1930-4 - Aquaplast RT Custom Bolus, 4.8mm, 43cm x 43cmRT-1931-4 - Aquaplast RT Custom Bolus, 4.8mm, 30cm x 45cmRT-1969 - Aquaplast Prone U-Frame, 4.8mm 4.8mm 40%RT-1989 - Aquaplast U-Frame, Std, 4.8mm 4.8mm 40%RT-1989L - Aquaplast RT U-Frame, 4.8 mm, LongRT-1989S - Aquaplast Slim U-Frame, Std, 4.8mm 4.8mm 40%RT-1989SO - Aquaplast Slim Org U-Frame, Std, 4.8mm 4.8mm 40%RT-1989-S3 - Aquaplast RT Disposable Slimline Split-Frame, 4.8 mm, perforated, 8 cm GapRT-1989SX - Aquaplast RT Slimline U-Frame, 4.8 mm, ExtendedRT-1999 - Aquaplast RT Sheet, 9" x 24", 4.8mm, PerforatedRT-7001 - Adapt-it Bolus Pellets, 1 lb.RT-7003 - Adapt-it Bolus Pellets, 3 lbs.RT-7003K - Adapt-It Fibreplast PelletsRT-B889KYCF - FibreplastHeadOnly Open View Integrated Shim Thermoplastic System(Box Qty1)RT-B889KYC - Fibreplast Head Only Integrated Shim Thermoplastic System (Box Qty 1)RT-B889KYESD - Fibreplast VP Head Only Curve S-Frame, 3.2mm with IntergraBiteRT-B889KYS - Fibreplast VP Head Only U-Frame, 3.2mm with IntegraBiteRT-B889KYSD - Fibreplast VP Head Only Portrait S-Frame, 3.2mm with IntegraBiteRT-B892KYESD - Fibreplast VP Hd & Shlder Curve S-Frame, 3.2mm with IntegraBiteRT-B892KYSD - Fibreplast VP Hd & Shlder Portrait S-Frame, 3.2mm with IntegraBiteRT-VIP-20CFHNSUB1C - Type-S Carbon Fiber Frame for reloadable thermoplastic masksRT-1779S-S3F - Aquaplast Splt Slim U-Frame GapRT-1776KYSGXF - Fibreplast Open Views HD Only Split U-Frame Ext.RT-1776KYSGXF - Fibreplast Open Views HD Only Split U-Frame ExtRT-1889KYSGLF - Fibreplast Open View Slim Split-Frame U-Frame Lng.



RT-1889KYFORF3 - Fibreplast 3-Point Mask, 3.2 mm, Variable PerfRT-1889KYFORF5 - Fibreplast 5-Point Mask, 3.2 mm, Variable PerfRT-A892YSD - Aquaplast RT VP Hd & Shldr Portrait S-Frame, 3.2mm, w/ Integrated ShimRT-A892SD - Aquaplast Hd & Shldr Portrait S-Frame, 3.2mm , Std Perf w/ Integrated ShimRT-A779SD - Aquaplast Hd Only Portrait S-Frame, 2.4mm, Std Perf w/ Integrated ShimRT-A782KSD - Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm, Std Perf w/ Integrated ShimRT-A892KSD - Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm, Std Perf w/ Integrated ShimRT-A889KYSD - Fibreplast VP Hd Only Portrait S-Frame, 3.2mm w/ Integrated ShimRT-A876KSDGLF - Fibreplast Open View Spt Hd Only S-Frame, 3.2mm Micro Perf w/ IntegratedShimRT-A892KYSDF - Fibreplast Open View Hd+Shdr 3.2mm Variable Perf w/ Integrated ShimRT-A892KYSD - Fibreplast VP HD+Shldr Portrait S-Frame, 3.2mm w/ Integrated Shim8002046 - Neuro Head Holder8002048 - DSA-2Q Head Holder8002049 - DSA-2T Head Holder8002069 - Head Holder Pad8002505 - DSA-3Q Head HolderRT-5100 - Symphony™ Patient TrolleyRT-5100-01 - Symphony Standard Transfer SurfaceRT-5100-02 - Symphony Portrait Head/Neck Transfer SurfaceRT-5100-04 - Symphony BoS Head/Neck Transfer SurfaceRT-4700-01 - Insight™ MR OverlayRT-4700-02 - Insight™ MR Head Coil HolderRT-4700-03 - Insight™ MRI Bridge with Body Coil HolderRT-4700-10 - Insight MR Overlay and Coil Holder PackageRT-4484 - Blue Mask Foam, 9" x 12" x 1/8" thick w adhesive backingRT-4484-16 - Blue Mask Foam, 9" x 12" x 1/16" thick w adhesive backingRT-4484-16/4X6 - Blue Mask Foam, 4" x 6" x 1/16" thick, pkg. of 8 w adhesiveRT-4485 - Precut RT-4535BOS series headframe foam shimRT-4485CL - Replacement BoS Pin, 100pkRT-4485CL2 - BoS Headframe replacement pin Kit 2.1 (100 pins)RT-4489PFO1 - Prone Face CushionRT-7010TTA - Adapter TT-A CouchtopRT-SP001 - Spare Parts Kit 001RT-4546H - 5.5" Foam HeadrestRT-4551KVA-ELK - kVue Interface Plate for Precise CouchRT-4551KVA-ETR - kVue Interface Plate for ETR CouchRT-4551KVA-TXT - kVue Interface Plate forTXT CouchRT-4551KVA-ZXT - kVue Interface Plate, ZXT CouchRT-4551KVOTM - KVue one touch mechanism Service ReplacementRT-4551KVPP - kVue Pinch Point upgrade kitRT-4551KV-PRS01 - kVue PRS Calibration KitRT-4551KV-PRS02 - kVue Upgrade Kit, Varian PRSRT-0001A - Mesh Pan Liner 9" x 15"RT-0001C - Mesh Pan Liner (19" x 25")RT-0001D - Mesh Pan Liner (30" x 36")RT-0001E - Mesh Pan Liner (24" x 36")RT-4551KVTBHRD - Hardware Kit for Varian TrueBeam pedestalRT-4551KVVHRD - Hardware Kit for Exact Couch pedestalRT-4551KVVHRD-01 - PRS TrueBeam Hardware KitRT-4451KVVHRD-01 - PRS TrueBeam Exact Couch Top Hardware Kit



RT-4517-Hooks - "S" Hooks 10 per pkRT-4517-HOSE - Vac-Q-Fix adapter hose - SingleStep ValveRT-4517-HOSE-MADAPT - White male adapter - Vac-Q-Fix HoseRT-4517-HOSE-MT - Vac-Q-Fix adapter hose - Economy ValveRT-4517-HOSEMT2SS - MT Hose adapterRT-4517-HOSEMTFADAPT - Female MT adapter ONLY for Vac-Q-Fix HoseRT-4517-HOSEMTMADAPT - Male MT adapter for Vac-Q-Fix HoseRT-4517-HOSE-SSADAPT - Female Single Step Valve adapterRT-4517-HOSE-QFSS - Vac-Q-Fix male adapter hoseRT-4517-HSCP - Hose Set (1 small hose, 1 coupling) For RT-PumpQ1, Pump220Q18002205 - Replacement Chin Straps, Neuro Head Holder8002206 - Replacement Pad Kit, Neuro Head Holder8000158 - kVue Standard Insert Panel8002583 - Proton kVue One Back Panel8002528 - Proton kVue One Assembly, Varian Mounting8002573 - CBCT, Penn TableRT-4527ELK - Adapter for Precise CouchtopRT-4527ETR-J - AccuFix Cantilever Board Adapter, J ShapedRT-4527EXA - Exact Direct Indexing AdapterRT-4527EXA475 - Adapter, Narrow Exact Style, 475mm between scallops, 500mm wideRT-4527EXAG - Adapter for Exact CouchtopRT-4527IPS - Adapter for IPPS CouchtopRT-4527LMI3 - MI AdapterRT-4527LTOMO - Accufix Tomo Therapy Couchtop adapterRT-4527MTP - AccuFix MT Prodigy AdapterRT-4527MTPCT - AccuFix MT Prodigy AdapterRT-4527MTPCT-S - Accufix Prodigy Adapter Kit 50.3 cm wideRT-4527PETCT - AccuFix Gemini/Discovery AdapterRT-4527QFIX - AccuFix Qfix AdapterRT-4527ZXT - AccuFix ZXT AdapterRT-4551KV-SRT-A1 - Forte Robot Adaptor Kit MountRT-4551KVA-02 - kVue One Proton 2 Coupler Interface PlateDRT-4521CSA - Prone Cranial Spinal Axis Kit DRT-4525L - Accufix Cantilever Head & Neck Device DRT-4525TILT - Tilt-Pro Tilting Base DRT-4543 - Quest Carbon Fiber Breast Board DRT-4544 - Access Prone Breast Treatment Device DRT-4546 - Access Supine Breast Treatment Device w/foam DRT-4546AA - Access Arm Support DRT-4546AW - Access Wrist Cup DRT-4546MRI - Access Supine MR & Breast Treatment Device w/foam DRT-4545CV-17 - Access ClearVue Prone Breast RefurbishedDRT-4552 - Portrait Intracranial, Head and Neck Device DRT-4558-1 - Stradivarius SBRT Overlay, No Accessories DRT-4558KV2 - 38cm Variable Height Bridge-Stradivarius SBRT DRT-4558KV3 - 48cm Variable Height Bridge-Stradivarius SBRT DRT-4558KV4 - Compression Paddle for Stradivarius,SBRT System DRT-4558KV4-01 - Compression Paddle for SBRT System DRT-4517-230120T80F90 - Vac-Q-Fix Cushion, 120/80cm x 230cm, 90L fill DRT-4517-4079VF15 - Vac-Q-Fix Cushion, 40cm x 80cm, 15L fill DRT-4546-01 - Access Supine Breast Treatment Device Refurbished



DRT-4558KV1 - kVue Stradivarius SBRT insert no accessories DRT-4551KV1 - kVue Standard Indexing Insert DRT-4551CART - kVue Storage Cart DRT-4464-02 - SofTouch Elite Belly BoardRT-4558CB02 - ZiFix Abdominal/Thoracic Motion Control SystemDRT-4558CB02 - ZiFix Abdominal/Thoracic Motion Control SystemRT-4600-02 - Standalone Encompass compatible w/ HexaPOD, Device

Composición cuali-cuanti porcentual exacta (si corresponde):

No Corresponde

Indicación/es autorizada/s:

Posicionamiento e inmovilización de cabeza y tronco del paciente durante el tratamiento deRadioterapia.

Período de vida útil (si corresponde):

10 años

Método de Esterilización (si corresponde):

No corresponde, no estéril

Forma de presentación:

Por unidad

Condición de venta:

Venta Exclusiva a Profesionales e Instituciones Sanitarias

Nombre del fabricante:

WFR / Aquaplast Corporation / Anholt Technologies inc. dba Qfix

Lugar/es de elaboración:440 Church Road, Avondale, PA 19311, ESTADOSUNIDOS

En nombre y representación de la firma PHOTONIX S.R.L , el responsable legal y el responsabletécnico declaran bajo juramento que los productos médicos enumerados en el presente Anexo,satisfacen los Requisitos Esenciales de Seguridad y Eficacia (R.E.S.E.) previstos por laDisposición ANMAT N° 4306/99, que cumplen y se encuentra a disposición de la AutoridadSanitaria la documentación técnica que contenga los requerimientos solicitados en los AnexosIII.B y III.C del Reglamento Técnico aprobado por Disposición ANMAT N° 2318/02 (TO 2004) yDisposición ANMAT Nº 727/13.



CUMPLIMIENTO DE R.E.S.E. DISPOSICIÓN ANMAT N° 4306/99 Y GESTIÓN DERIESGO

ENSAYO/VALIDACION/GESTION DERIESGO

LABORATORIO/N° DEPROTOCOLO

FECHA DEEMISIÓN

NO APLICA NO APLICA NO APLICA

El responsable legal y su responsable técnico son responsables de la veracidad de ladocumentación e información presentada y declaran bajo juramento mantener en suestablecimiento y a disposición de la autoridad sanitaria la documentación allí declarada y la queestablece la Disposición 727/13, bajo apercibimiento de lo que establece la Ley N° 16.463, elDecreto N° 341/92 y las que correspondan del Código Penal en caso de falsedad.En caso de inexactitud o falsedad de la información o documentación, la Administración Nacionalpodrá suspender, cancelar, prohibir la comercialización y solicitar retiro del mercado de lo yaautorizado e iniciar los sumarios que pudieran corresponder.

LUGAR Y FECHA: Argentina, 09 abril 2018

Responsable LegalFirma y Sello

Responsable TécnicoFirma y Sello

Ministerio de Salud

Secretaría de Regulación y Gestión SanitariaA.N.M.A.T.

La presente DECLARACIÓN DE CONFORMIDAD ha sido emitida de acuerdo con las previsiones



de la Disposición ANMAT Nº 727/13 y N°5706/17, quedando inscripta la modificación en elRegistro Nacional de Productores y Productos de Tecnología Médica (R.P.P.T.M.) a favor dePHOTONIX S.R.L bajo el número PM 2202-10 en la Ciudad de Buenos Aires a los días 09 abril2018Se autoriza la comercialización del/los producto/s identificados en la presente declaración deconformidad, la cual mantendrá la vigencia que consta en la Declaración inicial revisión 00 oDisposición Autorizante o su reválida.

Dirección de Evaluación de RegistroFirma y Sello

Dirección Nacional de Productos MédicosFirma y Sello

Tramitada por Expediente N°: 1-0047-3110-001454-18-1



DECLARACIÓN DE CONFORMIDAD DE …€¦ · INMOVILIZADORES DE PACIENTE, CABEZA Y TRONCO, PARA USO...

Documents

Transcript of DECLARACIÓN DE CONFORMIDAD DE …€¦ · INMOVILIZADORES DE PACIENTE, CABEZA Y TRONCO, PARA USO...