QUANTUM™ CT Overlay
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qfix
Identity
- Trade Name
- QUANTUM™ CT Overlay FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- GE Gen2 QUANTUM CT Overlay for GE GT 1700 and GE NG2000V CT Scanners FDA UDI
- Model / Reference
- RT-4550GER2 EUDAMEDFDA UDICouchtops, Overlays, and Multipurpose Devices EUDAMED
- Description
- GE Gen2 QUANTUM CT Overlay for GE GT 1700 and GE NG2000V CT Scanners FDA UDI
Identifiers
- Catalog Number
- RT-4550GER2 FDA UDI
- Primary DI / UDI-DI
- 10841962111291 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621COUCHTOPSMPD6F EUDAMED
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5770 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 207 Centimeter FDA UDI
Category: Indexed-immobilization patient positioning system
QUANTUM™ CT Overlay by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI d308cc04-b5dc-49ca-bc4c-4fed28f4a3c1 36 fields · synced Jun 19, 2026
- EUDAMED d6437918-512e-4033-a6bf-83ea28bb5c0d 61 fields · synced Jun 19, 2026