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Centricity Radiology RA600 v7.0 +2 more models
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 2022296-x
Identity
- Trade Name
- Centricity Radiology RA600 v7.0; Centricity Cardiology CA1000 v1.0; Centricity Digital Hardcopy (DHC) v1.0 EUDAMED
- Device Name
- Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy EUDAMED
- Model / Reference
- 2022296-x EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-2022296-xMH EUDAMED
- Basic UDI-DI
- B-2022296-xMH EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Centricity Radiology RA600 v7.0 +2 more models by GE Healthcare — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — 3 models
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 | K042525 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-2022296-xMH | 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 (2)
- EUDAMED d2b5a68c-5b8e-4740-a82d-f65140525969 61 fields · synced Oct 6, 2026
- FDA 510(k) K042525 1 fields · synced May 18, 2026