Dispositivo de Posicionamento e Imobilização de Paciente para Tratamento de Radioterapia
Registro cancelado em 15/09/2025 segundo a ANVISA.
Nome do produto
Dispositivo de Posicionamento e Imobilização de Paciente para Tratamento de Radioterapia
Número de registro
81932410004
Nome técnico
Classe de risco
I
Processo
25351482164202399
Razão social
Fabricante
País de fabricação
BRASIL
Apresentações / Modelos(281)
MR7677-25NVacuum Cushion for Klarity ATHENATM Breast System, Klarity valve
R-1636920x610mm, 1.6mm, 36% perf.
R-1636A460x610mm, 1.6mm, 36% perf.
R-2415920x610mm, 1.6mm, 36% perf.
R-2415A460x610mm, 1.6mm, 36% perf.
R-2422920x610mm, 1.6mm, 36% perf.
R-2422A460x610mm, 1.6mm, 36% perf.
R-2436920x610mm, 1.6mm, 36% perf.
R-2436A460x610mm, 1.6mm, 36% perf.
R-3242920x610mm, 1.6mm, 36% perf.
R-3242A460x610mm, 1.6mm, 36% perf.
R-4000EThermoplastic Bolus Sheet 15x15cm, 4.0mm
R-4000FThermoplastic Bolus Sheet 30x30cm, 4.0mm
R-4000GThermoplastic Bolus Sheet 20x23cm, 4.0mm
R-PRT2-2415P-Type 2-point Head Mask 2.4mm, 15% perf.
R-PRT3-2415P-Type 3-point Head Mask 2.4mm, 15% perf.
R-PRT5-2415P-Type 5-point H&S Mask 2.4mm, 15% perf.
R-PRT31-2415P-Type 3-point Head Mask 2.4mm, 15% perf., with rounded neck
R-PRT44-2415P-Type 3-point Head Mask 2.4mm, 15% perf., with neck flap
R-PRTL-2415P-Type 4-point H&S Mask 2.4mm, 15% perf.
R-SVT-3Sleeve&Pin for S and V-type masks
R31-2400MBreast Mask for Klarity Breastboard 2.4mm, non perf.
R31-2436MBreast Mask for Klarity Breastboard 2.4mm, 36% perf.
R91-2400MPelvic Mask for Klarity Breastboard 2.4mm, non perf.
R91-2436MPelvic Mask for Klarity Breastboard 2.4mm, 36% perf.
R323-B2436SBRT Thorax Mask
R401L-3242O-Type 6-point Pelvic Mask 3.2mm, 42% perf., with traditional clamps
R406-1Stereotactic Head Mask Head Frame Set (Type A)
R406-3Stereotactic Head Mask Head Frame Set (Type A), 2cm wider
R406-11Stereotactic Head Mask Head Frame Set (Type A), with round neck
R408Stereotactic Head Mask Head Frame set for BrainLab system B type
R408-2Stereotactic H&S Mask H&S Frame Set (Type B)
R408-5Stereotactic Head Mask Head Frame set for BrainLab system B type, with round neck
R408A-1Stereotactic Head Mask for ExacTrac Dynamic System, white
R420WStandard ProfileFrame™ 2.4mm, 36% perf.
R421WStandard ProfileFrame™ 2.4mm, 36% perf., 2" longer
R430UCEzeFrame™,3.2mm
R430WStandard ProfileFrame™ 3.2mm, 42% perf.
R431WStandard ProfileFrame™ 3.2mm, 42% perf., 2" longer
R450UContourFrame™, 2.4mm
R460SDPediatric S-Type H&S Mask 2.4mm, 36% perf.
R460SHTS-Type Head Mask 2.4mm, 36% perf.
R460STS-Type H&S Mask 2.4mm, 36% perf.
R460VDPediatric V-Type H&S Mask 2.4mm, 36% perf.
R460VHTV-Type Head Mask 2.4mm, 36% perf.
R460VTV-Type H&S Mask 2.4mm, 36% perf.
R461-1WIMRT ProfileFrameTM 3.2mm, with extended neckline
R461-8SHTFS-Type OpenFace Head Mask 3.2mm
R461-8STFS-Type OpenFace H&S Mask 3.2mm
R461-8VHTFS-Type OpenFace Head Mask 3.2mm
R461-8VTFS-Type OpenFace H&S Mask 3.2mm
R461SHTS-Type Head Mask 3.2mm, 42% perf.
R461STS-Type H&S Mask 3.2mm, 42% perf.
R461VHTV-Type Head Mask 3.2mm, 42% perf.
R461VTV-Type H&S Mask 3.2mm, 42% perf.
R470SReloadable S-Type H&S Mask 2.4mm, 36% perf.
R470SHReloadable S-Type Head Mask 2.4mm, 36% perf.
R471SReloadable S-Type H&S Mask 3.2mm, 42% perf.
R471SHReloadable S-Type Head Mask 3.2mm, 42% perf.
R504-1Foam Head Support Set includes A-E
R504-2Foam Head Support Set includes A-F
R504-AFoam Head Support Color Mauve
R504-BFoam Head Support Color Red
R504-CFoam Head Support Color Green
R504-DFoam Head Support Color Dark Blue
R504-EFoam Head Support Color Blue
R504-FFoam Head Support Color Black
R507Acrylic Head Support Set includes A-F
R507-5Acrylic Head Support with hole 6 heights each set
R507-AAcrylic Head Support A
R507-BAcrylic Head Support B
R507-CAcrylic Head Support C
R507-DAcrylic Head Support D
R507-EAcrylic Head Support E
R507-FAcrylic Head Support F
R507-TDedicated Headrest for AccuCushions
R516-15VWedge size 71x257x178mm
R516-16LEGWedge size 149x350x400mm
R516-43VWedge size 142x308x533mm
R516-45VWedge size 171x171x610mm
R516-178LWedge size 139x178x381mm
R902-1PelvicFix™ insert 2.4mm non perf 18"x22" (46X56cm)
R902-1APelvicFix™ Mask 2.4mm, non perf., 46x56cm
R902-3PelvicFix™ insert 3.2mm 42% perf 18"x22" (46X56cm)
R902-3APelvicFix™ Mask 3.2mm, 42% perf., 46x56cm
R902-7PelvicFix™ insert 3.2mm non perf 18"x22" (46X56cm)
R902-7APelvicFix™ Mask 3.2mm, non perf., 46x56cm
R902-24CAPelvicFix™ Mask 2.4mm, 46x56cm, with AccuPerf
R902-32CAPelvicFix™ Mask 3.2mm, 46x56cm, , with AccuPerf
R7131-5NLTVacuum Bag for knee support 80cm × 28cm, 5L fill
R7202-9NLRHaed & Shoulder Vacuum Cushion 62.5 × 58.2 cm, 9 Liters Fill
R7231-15NLR-OFull Body Vacuum Bag 134.7 x 52 cm, 15 Liters Fill
R7569-12NLR-OBody Vacuum Cushion 94.5 x 53 cm, 12 Liters Fill
R7641-25NLB2Vacuum Bag for body support 120cm × 80cm, 25L fill
RB-BHMF-3210Blue medium Proton Therapy OpenFace Head Mask 10% perforation , 3.2mm 37cm wide
RB-BSLF-3210Blue medium Proton Therapy OpenFace Head Mask 10% perforation , 3.2mm 37cm wide
RB-ESH3-3210CNE-type Icon head Masks
RB430W-3210U-type Head Mask 10% perforation , 3.2mm
RB431W-3210U-type Extended Head Mask 10% perforation , 3.2mm
RB431W-3210FU-type Extended OpenFace Head Mask 10% perforation , 3.2mm
RB461-6SHTEMS-type OpenEM Head Mask with AccuPerf , 3.2mm
RB461-6SHTFS-type OpenFace Head Mask with AccuPerf , 3.2mm
RB461-6STEMS-type Head & Shoulder OpenEM Mask with AccuPerf , 3.2mm
RB461-6STFS-type Head & Shoulder OpenFace Mask with AccuPerf , 3.2mm
RB461-3210SHTS-type Head Mask 10% perforation , 3.2mm
RB461-3210STS-type Head & Shoulder Mask 10% perforation , 3.2mm
RBSRS-3210QStereotactic masks for Encompass system
RBSRS-3210QFOpenFace type Stereotactic masks for Encompass system
RD104-2022NPediatric O-Type 3-point Head Mask 2.0mm, 22% perf.
RD105-2022NO-Type 3-point Head Mask 2.0mm, 22% perf.
RD105-2422NO-Type 3-point Head Mask 2.4mm, 22% perf.
RD107-2022NO-Type 3-point Head Mask 2.0mm, 22% perf., with neck flap
RD107-2422NO-Type 3-point Head Mask 2.4mm, 22% perf., with neck flap
RD202-2022NPediatric O-Type 4-point H&S Mask 2.0mm, 22% perf.
RD204-2022NPediatric O-Type 5-point H&S Mask 2.0mm, 22% perf.
RD206-2022NO-Type 4-point H&S Mask 2.0mm, 22% perf.
RD206-2422NO-Type 4-point Head Mask 2.4mm, 22% perf.
RD207-2022NO-Type 5-point H&S Mask 2.0mm, 22% perf.
RD207-2422NO-Type 5-point Head Mask 2.4mm, 22% perf.
RD260L-2422CO-Type 4-point N&S Mask 46.3x37.6cmx2.4mm,22% perf. All edges are smooth
RD260M-2422CO-Type 4-point N&S Mask 40.8x38.8cmx2.4mm,22% perf. All edges are smooth
RD260S-2422CO-Type 4-point N&S Mask 36x39cmx2.4mm,22% perf. All edges are smooth
RD301-3242O-Type 2-point Breast Mask 3.2mm, 42% perf.
RD305-3242CO-Type Breast Mask 25x40.8cmx3.2mm,42% perf. All edges are smooth
RD400L-3242CO-Type 6 point Breast &Belly Mask 53.7x46.3cmx3.2mm,42% perf. All edges are smooth
RD400XL-3242CO-Type 6 point Breast &Belly Mask 53.3x48.7cmx3.2mm,42% perf. All edges are smooth
RD413L-3242CO-Type 6 point Breast &Belly Mask 53.5x46.3cmx3.2mm,42% perf. All edges are smooth
RD413M-3242CO-Type 6 point Breast &Belly Mask 53.5x39.8cmx3.2mm,42% perf. All edges are smooth
RD413S-3242CO-Type 6 point Breast &Belly Mask 53.5x33.3cmx3.2mm,42% perf. All edges are smooth
RD901-3242O-Type 4-point Pelvic Mask 3.2mm, 42% perf.
RD903M-3242CO-Type 4 point Breast &Belly Mask 53.5x39.8cmx3.2mm,42% perf. All edges are smooth
RD903XL-3242CO-Type 4 point Breast &Belly Mask 53.5x48.7cmx3.2mm,42% perf. All edges are smooth
RDLG104-2012CGreenLite Pediatric O-Type 3-point H&S Mask 26.6x26cmx2.0mm,12% perf. All edges are smooth
RDLG105-24AGreenLite IMRT O-Type 3-point Head Mask 2.4mm
RDLG105-32AGreenLite IMRT O-Type 3-point Head Mask 3.2mm
RDLG105-2412CGreenLite O-Type 3-point Head Mask 34x32.5cmx2.4mm,12% perf. All edges are smooth
RDLG107-24AGreenLite IMRT O-Type 3-point Head Mask 2.4mm, with neck flap
RDLG107-32AGreenLite IMRT O-Type 3-point Head Mask 3.2mm, with neck flap
RDLG107S-2412CGreenLite O-Type 3-point Head Mask 34x32.5cmx2.4mm,12% perf. All edges are smooth
RDLG202-2012CGreenLite O-Type 4-point N&S Mask 32.2x42.8cmx2.0mm,12% perf. All edges are smooth
RDLG204-2412CGreenLite Pediatric O-Type 5-point H&S Mask 42.8x39.1cmx2.4mm,12% perf. All edges are smooth
RDLG206-24AGreenLite IMRT O-Type 4-point H&S Mask 2.4mm
RDLG206-32AGreenLite IMRT O-Type 4-point H&S Mask 3.2mm
RDLG206-2412CGreenLite O-Type 4-point H&S Mask 48.6x34.3cmx2.4mm,12% perf. All edges are smooth
RDLG207-24AGreenLite IMRT O-Type 5-point H&S Mask 2.4mm
RDLG207-32AGreenLite IMRT O-Type 5-point H&S Mask 3.2mm
RDLG207-2412CGreenLite O-Type 5-point H&S Mask 45.6x48cmx2.4mm,12% perf. All edges are smooth
RDLG207L-2412CGreenLite O-Type 5-point H&S Mask 48x49cmx2.4mm,12% perf. All edges are smooth
RG-BHM-2436KG OpenFace Head Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf.
RG-BHM-2436KG Head Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf., 37cm wide
RG-BHM-2436FKG Head Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf., 37cm wide With cranial flap lock
RG-BHM-3242KG Head Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf., 37cm wide
RG-BHM-3242KG OpenFace Head Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf.
RG-BHM-3242FKG Head Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf., 37cm wide With cranial flap lock
RG-BHS-2436KG Head Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf., 32cm wide
RG-BHS-2436FKG Head Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf., 32cm wide With cranial flap lock
RG-BHS-3242KG Head Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf., 32cm wide
RG-BHS-3242FKG Head Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf., 32cm wide With cranial flap lock
RG-BSL-2436KG OpenFace H&S Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf.
RG-BSL-2436KG H&S Mask for Proton Therapy Fits Qfix BoS, 2.4mm, 36% perf.
RG-BSL-3242KG OpenFace H&S Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf.
RG-BSL-3242KG H&S Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf.
RG-BSL-3242FKG H&S Mask for Proton Therapy Fits Qfix BoS, 3.2mm, 42% perf. With cranial flap lock
RG-ELH-2022KG Elekta-compatible Head Mask 2.0mm, 22% perf.
RG-ELH-2022NKG Elekta-compatible Head Mask 2.0mm, 22% perf., with nose hole
RG-ELS-2022KG Elekta-compatible H&S Mask 2.0mm, 22% perf.
RG-ELS-2022NKG Elekta-compatible H&S Mask 2.0mm, 22% perf. With nose hole
RG408-4ACKG Stereotactic Head Mask Head Frame Set (Type B)
RG408A-1Stereotactic Head Mask for ExacTrac Dynamic System, Green
RG420-1WKG IMRT ProfileFrameTM 2.4mm
RG420EU-Max™ 2.4mm 36% perf 10"x10" WideFace mask w/Klarity Green™
RG420WKG Standard ProfileFrame™ 2.4mm, 36% perf.
RG421EU-Max™ 2.4mm 36% perf 10"x12" WideFace mask w/Klarity Green™
RG421WKG Standard ProfileFrame™ 2.4mm, 36% perf., 2" longer
RG430-1WKG IMRT ProfileFrameTM 3.2mm
RG430EU-Max™ 3.2mm 36% perf 10"x10" WideFace mask w/Klarity Green™
RG430WKG Standard ProfileFrame™ 3.2mm, 42% perf.
RG431EU-Max™ 3.2mm 36% perf 10"x12" WideFace mask w/Klarity Green™
RG431WKG Standard ProfileFrame™ 3.2mm, 42% perf., 2" longer
RG460-1WKG IMRT ProfileFrameTM 2.4mm, with extended neckline
RG460-4SHTKG IMRT S-Type Head Mask 2.4mm
RG460-4STKG IMRT S-Type H&S Mask 2.4mm
RG460-4VHTKG IMRT V-Type Head Mask 2.4mm
RG460-4VTKG IMRT V-Type H&S Mask 2.4mm
RG460-5SHTKG IMRT S-Type Head Mask 2.4mm, with extended neckline
RG460-5VHTKG IMRT V-Type Head Mask 2.4mm, with extended neckline
RG460-8SHTEMKG S-Type OpenEM Head Mask 2.4mm
RG460-8STEMKG S-Type OpenEM H&S Mask 2.4mm
RG460-8VHTEMKG V-Type OpenEM Head Mask 2.4mm
RG460-8VTEMKG S-Type OpenEM H&S Mask 2.4mm
RG460SCKG Narrow Shoulder S-Type H&S Mask 2.4mm, 36% perf.
RG460SHTKG S-Type Head Mask 2.4mm, 36% perf.
RG460STKG S-Type H&S Mask 2.4mm, 36% perf.
RG460VCKG Narrow Shoulder V-Type H&S Mask 2.4mm, 36% perf.
RG461-4SHTKG IMRT S-Type Head Mask 3.2mm
RG461-4STKG IMRT S-Type H&S Mask 3.2mm
RG461-4VHTKG IMRT V-Type Head Mask 3.2mm
RG461-4VTKG IMRT V-Type H&S Mask 3.2mm
RG461-5SHTKG IMRT S-Type Head Mask 3.2mm, with extended neckline
RG461-5VHTKG IMRT V-Type Head Mask 3.2mm, with extended neckline
RG461-8SHTEMKG S-Type OpenEM Head Mask 3.2mm
RG461-8STEMKG S-Type OpenEM H&S Mask 3.2mm
RG461-8VHTEMKG V-Type OpenEM Head Mask 3.2mm
RG461-8VTEMKG S-Type OpenEM H&S Mask 3.2mm
RG461SCKG Narrow Shoulder S-Type H&S Mask 3.2mm, 42% perf.
RG461SHTKG S-Type Head Mask 3.2mm, 42% perf.
RG461STKG S-Type H&S Mask 3.2mm, 42% perf.
RG461VCKG Narrow Shoulder V-Type H&S Mask 3.2mm, 42% perf.
RG464-1WKG IMRT ProfileFrameTM 3.2mm, with extended neckline
RG550-CEL2Green Head Support AccuCushion™ Specially for Elekta ICON Size: 34×17.5×2.5cm
RG550-H2Green Head Support AccuCushion™ Size: 25.8×40.5cm
RG550-MGreen Head Support AccuCushion™ Size: 25×20cm
RG550-S1Green Head Support AccuCushion™ Size: 25×45cm
RG560-SH1Green Head & Neck AccuCushion™ Size: 52×50cm
RG560-SH2Green Head & Neck AccuCushion™ Size: 52×47cm
RG560-SH3Green Head & Neck AccuCushion™ with higher shoulder parts Size: 52×50cm
RG560-SH5Green Head & Neck AccuCushion™ Size: 60×48.5cm
RG570-SGreen Body AccuCushion™ Size: 60×50cm
RG570-S1Green Body AccuCushion™ Size: 60×40cm
RLG-ESH1-2412CLight Green E-Type Fraxion head Mask 12% perforation, 2.4mm
RLG-ESH2-2412CLight Green E-Type Fraxion Rounded Head Mask 12% perforation, 2.4mm
RLG-ESH2-2412CNLight Green E-Type Icon head Mask 12% perforation, 2.4mm
RLG-PRT3-24AK LIGHT GREEN IMRT P-Type 3-point Head Mask 2.4mm
RLG-PRT3-24AFK LIGHT GREEN IMRT P-Type 3-point 2.4mm Head Mask, Open Face
RLG-PRT3-24AFK LIGHT GREEN IMRT P-Type 3-point 2.4mm Head Mask, Open Face
RLG-PRT3-2412CK LIGHT GREEN IMRT P-Type 3-point Head Mask 2.4mm, 12% perf. Solid Edge
RLG-PRT5-24AK LIGHT GREEN IMRT P-Type 5-point Head Mask 2.4mm
RLG-PRT5-24AFK LIGHT GREEN IMRT P-Type 5-point 2.4mm Head &Should Mask Open Face
RLG-PRT5-32AFK LIGHT GREEN IMRT P-Type 5-point 3.2mm Head &Should Mask Open Face
RLG-PRT5-2412CK LIGHT GREEN IMRT P-Type 5-point Head Mask 2.4mm, 12% perf., Solid Edge
RLG-PRT44-2412CK LIGHT GREEN IMRT P-Type 3-point Head Mask 2.4mm, 12% perf., with necK
RLG460SHTKlarity Light Green S-type Head Mask with 36% perforation, 2.4 mm
RLG461SHTKlarity Light Green S-type Head Mask with 42% perforation, 3.2 mm
RNB-11A package of long and short tongue depressor, Right and left tongue diverter, 1 removal tool
RNB-100Klarity BiteLok™ standard version (1 BiteLok mouthpiece, 1 two putty packets, 1 QuickFit™ tool, long and short tongue depressor, Right and left tongue diverter,1 removal tool )
RNB-100AKlarity BiteLok™ simple version (1 BiteLok mouthpiece, 1 QuickFit™ tool, 1 two putty packets )
RP-500Thermoplastic Bolus Pellets 500g/bag
R7100-1NL
R7101-3NL
R7102-08NL
R7105-5NL
R7106-3NL
R7200-5NL
R7202-7NLR
R7202-8NL
R7206-16NL
R7207-5NL
R7300-9NL
R7301-8NL
R7301-8NLB
R7400-13NL
R7401-15NL
R7401-15NLB
R7405-11NL
R7406-18NL
R7422-30NL
R7504-28NL
R7504-28NLB
R7504-30NL
R7504-30NLB
R7504-35NL
R7505-30NL
R7506-34NL
R7506-34NLB
R7507-33NL
R7507-36NL
R7507-36NLB
R7507-42NL
R7508-45NL
R7509-51NL
R7510-11NL
R7512-45NL
R7513-68NL
R7514-33NL
R7524-85NL
R7524-85NLB
R7540-56NL
R7540-56NLB
R7541-13NL
R7541-13NLB
RNB-YJ Two putty packets (10pcs /bag)
Instruções de Uso e Arquivos(1)
| Código | Tipo | Arquivo | Expedição | Expediente |
|---|---|---|---|---|
| T28536725 | INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO | MANUAL MA_SCARAS KLARITY RT MEDICAL.pdf | 07/03/2025, 12:33 | 0309662257 |
INSTRUÇÕES DE USO OU MANUAL DO USUÁRIO DO PRODUTO
A atualização destes documentos é executada pela empresa responsável pela regularização do produto.
Documentos Técnicos(1)
| Petição / Protocolo | Data | Assunto | Situação |
|---|---|---|---|
| 0779319231Primária | 07/08/2023 | MATERIAL – Notificação de Dispositivo Médico Classe I | Publicado deferimento |
MATERIAL – Notificação de Dispositivo Médico Classe I
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