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Xeleris V Processing & Review System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 5927911Model Xeleris V Processing and Review SystemRef 5955981
Identity
- Trade Name
- Xeleris V Processing & Review System EUDAMED
- Device Name
- Xeleris V Processing and Review System EUDAMED
- Model / Reference
- Xeleris V Processing and Review System EUDAMED5927911 EUDAMED5955981 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278614933 EUDAMED00195278822383 EUDAMED
- Basic UDI-DI
- 8406821BUG00344HF EUDAMEDB-00195278822383 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Xeleris V Processing & Review System by GE Medical Systems Israel, Functional Imaging — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8406821BUG00344HF | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201103 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00344HF | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems Israel, Functional Imaging
- EUDAMED SRN
- IL-MF-000003062
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED f4919bb7-02c3-4c9c-883e-2bf44a05a3ba 61 fields · synced Jul 14, 2026
- EUDAMED 08608439-5fc1-40f0-a43f-8deb7422ac22 61 fields · synced May 18, 2026
- FDA 510(k) K201103 1 fields · synced May 18, 2026