Identity
- Trade Name
- CR 12-X EUDAMEDFDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- Digitizer 5151 EUDAMEDCR 12-X DIGITIZER FDA UDI
- Model / Reference
- 5W8AB EUDAMED5151/200 FDA UDI
- Description
- CR 12-X DIGITIZER FDA UDI
Identifiers
- Catalog Number
- 5W8AB FDA UDI
- Primary DI / UDI-DI
- 05414904151310 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05414904151310 EUDAMED
- 510(k) Number
- K131408 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11060201 SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS EUDAMED
- GMDN Term
- Computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Cr 12-X by Agfa NV — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: CR 12-X
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05414904151310 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (2)
- EUDAMED dfd14c39-8b51-4a9d-b64a-fe836ca79c77 61 fields · synced Jul 16, 2026
- FDA UDI dffd27a4-f3b1-4aab-b3a0-95f27b7726bb 36 fields · synced May 30, 2026