← Back to catalogue
Centricity Universal Viewer Zero Footprint Client v6.0
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref K2037DED/K2037DAED/K2037DBED/K2037DJED/K2037DKED/P2037DED/P2037DAED/P2037DBED510(k) K131977Ref 2093796-001
Identity
- Trade Name
- Centricity Universal Viewer Zero Footprint Client v6.0 EUDAMEDCENTRICITY FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Centricity Universal Viewer Zero Footprint Client EUDAMED
- Model / Reference
- K2037DED/K2037DAED/K2037DBED/K2037DJED/K2037DKED/P2037DED/P2037DAED/P2037DBED EUDAMED2093796-001 EUDAMEDUNIVERSAL VIEWER ZFP CLIENT 6.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682102988 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682102988 EUDAMED
- 510(k) Number
- K131977 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
- -1192 EUDAMED
- Market of Registration
- France 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Centricity Universal Viewer Zero Footprint Client v6.0 by GE Healthcare — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131977 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00840682102988 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (4)
- EUDAMED 61e01121-9bbc-4ce6-a121-c1c56f31edec 85 fields · synced Jun 19, 2026
- FDA UDI f4aa4733-81af-4adb-bdd0-dd806332be8a 33 fields · synced May 30, 2026
- EUDAMED 1cd7aa0f-87ed-4160-a26f-d3cdef7dc1ff 61 fields · synced Jun 18, 2026
- FDA 510(k) K131977 1 fields · synced May 18, 2026