FDA.report

kVue™ Portrait™ Proton

Primary DI
10841962109366
Brand
kVue™ Portrait™ Proton
Company
Qfix
Model
RT-4552KV-01
Catalog number
RT-4552KV-01
Device description
kVue Portrait Proton Head and Neck Insert
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JAICouch, radiation therapy, powered

Product Code Classifications

CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841962109366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084196210936610841962109366

GMDN Terms

TermDefinition
Patient positioner base plateA device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags

DUNS number
808875397
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120456Alta for HexaPODRT-4800-05RT-4800-052026-01-14
00841962120388Lumen AirShuttleXT-5100-80XT-5100-802025-12-02
00841962120395Symphony Locating Bar, PH StyleRT-5100-11PHRT-5100-11PH2025-12-02
00841962120401Portrait Head Only Mask Adapter for Access SupineRT-4546-03RT-4546-032025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineRT-4546-04RT-4546-042025-12-02
10841962119464Symphony Locating Bar, PH StyleRT-5100-11PHRT-5100-11PH2025-10-23
00841962119856IntegraBiteRT-A001RT-A0012025-11-13
00841962120340Edge Guide SystemRT-5100-55RT-5100-552025-09-11
00841962119467Alpine StirrupsRT-5100-54LRT-5100-54L2025-07-09
00841962119474Alpine StirrupsRT-5100-54RRT-5100-54R2025-07-09
00841962119481Symphony™RT-5100-48RT-5100-482025-07-09
00841962119498AirDrive Trolley™RT-5100-12RT-5100-122025-07-09
00841962119504Access Arm SupportRT-4546AA-01RT-4546AA-012025-07-09
00841962119511Access Wrist SupportRT-4546AW-01RT-4546AW-012025-07-09
00841962119528AirShuttle Locating BarRT-5100-11ERT-5100-11E2025-07-09
00841962119535AirShuttle Locating BarRT-5100-11RT-5100-112025-07-09
00841962119542AirShuttle Transfer HandleRT-5100-10-BRT-5100-10-B2025-07-09
00841962119559InfinityLock™RT-5100-10-ART-5100-10-A2025-07-09
00841962119573AirShuttle Transfer HandleRT-5100-10RT-5100-102025-07-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841962120401Portrait Head Only Mask Adapter for Access SupineQfixJAI2025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixJAI2025-12-02
00841962119504Access Arm SupportQfixJAI2025-07-09
00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
00841962119788Locating BarQfixJAI2025-07-09
00841962119870Opti-HandlesQfixJAI2025-07-09
00841962119887Opti-HandlesQfixJAI2025-07-09
00841962119894Opti-HandlesQfixJAI2025-07-09
00841962119900Opti-HandlesQfixJAI2025-07-09
00841962119917Opti-HandlesQfixJAI2025-07-09
03700383510215ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2025-04-10
03700383510000ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510017ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510031ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510048ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510079ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510086ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510154ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
03700383510178ORION SystemBIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.JAI2024-11-06
10841962111291QUANTUM™ CT OverlayQfixJAI2022-10-18
10841962118757VacQfix™QfixJAI2022-02-03
10841962118764VacQfix™QfixJAI2022-02-03
10841962118771VacQfix™QfixJAI2022-02-03
10841962118788VacQfix™QfixJAI2022-02-03
10841962118795VacQfix™QfixJAI2022-02-03
10841962118801VacQfix™QfixJAI2022-02-03
10841962118818VacQfix™QfixJAI2022-02-03
10841962118825VacQfix™QfixJAI2022-02-03