Identity
- Trade Name
- ViewPoint 6 EUDAMEDViewPoint FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- ViewPoint 6 EUDAMEDViewPoint 6 v6.14 FDA UDI
- Model / Reference
- ViewPoint 6 EUDAMED5896732 EUDAMED6. ver14 FDA UDI
- Description
- ViewPoint 6 v6.14 FDA UDI
Identifiers
- Catalog Number
- H47591YA FDA UDI
- Primary DI / UDI-DI
- 00195278517340 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00018GX EUDAMED
- Direct Marketing DI
- 00195278517340 EUDAMED
- 510(k) Number
- K203677 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ViewPoint 6 by GE Healthcare GmbH — Class IIa — 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 | 8406821BUG00018GX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare GmbH
- EUDAMED SRN
- DE-MF-000005087
Sources (2)
- EUDAMED b0cac72e-517f-403c-b2fa-5a59353ce017 61 fields · synced Jul 9, 2026
- FDA UDI 655c5258-5003-4eb6-ac2e-9d73a64fc21c 35 fields · synced May 30, 2026