← Back to catalogue

kVue™ Couch Top

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
kVue™ Couch Top FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
kVue IGRT Couchtop Baseframe w Moving Stealth Beam FDA UDI
Model / Reference
RT-4551KV FDA UDI
Description
kVue IGRT Couchtop Baseframe w Moving Stealth Beam FDA UDI

Identifiers

Catalog Number
RT-4551KV FDA UDI
Primary DI / UDI-DI
10841962109113 FDA UDI
FDA Product Code
JAI FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indexed-immobilization patient positioning system

kVue™ Couch Top by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA UDI 9bf7b248-a523-4a23-a3d3-1a4c39fd5775 35 fields · synced Jun 6, 2026