Identity
- Trade Name
- NX 4.0 EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- NX Software EUDAMED
- Model / Reference
- XCU8O EUDAMEDV4.0 FDA UDI
Identifiers
- Catalog Number
- XCU8O FDA UDI
- Primary DI / UDI-DI
- 05414904233320 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904272909YU EUDAMED
- 510(k) Number
- K180589 FDA UDI
- FDA Product Code
- JAA FDA UDI
- EMDN Code
- Z11030782 REMOTE CONTROL TABLES - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Nx 4.0 by Agfa NV — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5414904272909YU | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
Sources (2)
- EUDAMED 3efcc7b8-190e-49a5-8d38-952febae357b 61 fields · synced Jul 22, 2026
- FDA UDI 7da549b2-732a-4bf5-b37d-7abd374ac167 35 fields · synced May 30, 2026