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Centricity Radiology RA600 v8.0 - Centricity Cardiology CA1000 v2.0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2109571-x
Identity
- Trade Name
- Centricity Radiology RA600 v8.0; Centricity Cardiology CA1000 v2.0; Centricity Digital Hardcopy (DHC) v2.0 EUDAMEDCA1000 FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy EUDAMED
- Model / Reference
- 2109571-x EUDAMED2.0 SP 14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682125260 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682125260 EUDAMED
- 510(k) Number
- K063628 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
- Models / Variants
- Centricity Cardiology CA1000 v2.0 EUDAMEDFDA 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 Radiology RA600 v8.0 - Centricity Cardiology CA1000 v2.0 by GE Healthcare — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models
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-00840682125260 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 839509c5-ab8d-4134-8015-9ed674568061 61 fields · synced Jun 18, 2026
- FDA UDI 537dcd2d-66e3-4780-ad40-05a056e10ece 33 fields · synced May 30, 2026