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Centricity PACS - RA1000 v6.0
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2092152-x
Identity
- Trade Name
- Centricity PACS - RA1000 v6.0 EUDAMEDCentricity FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Centricity PACS EUDAMED
- Model / Reference
- 2092152-x EUDAMEDCPACS 6.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682104807 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682104807 EUDAMED
- 510(k) Number
- K110875 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software 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 PACS - RA1000 v6.0 by GE Healthcare — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K110875 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00840682104807 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED be043b81-1220-40f9-9e15-283a36446d3d 61 fields · synced Jul 8, 2026
- FDA UDI 2eed5b3b-cf08-4fe7-987d-c67205697ba1 33 fields · synced May 29, 2026
- FDA 510(k) K110875 1 fields · synced May 18, 2026