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Xeleris 4 DR Processing & Review Workstation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5782764Model Xeleris 4 DR Processing and Review Workstation
Identity
- Trade Name
- Xeleris 4 DR Processing & Review Workstation EUDAMEDXeleris Processing and Review Workstation FDA UDI
- Generic Name
- Nuclear medicine system workstation FDA UDI
- Device Name
- Xeleris 4 DR Processing and Review Workstation EUDAMED
- Model / Reference
- Xeleris 4 DR Processing and Review Workstation EUDAMED5782764 EUDAMED4.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682134897 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682134897 EUDAMED
- 510(k) Number
- K153355 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Nuclear medicine system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- 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
No
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
Xeleris 4 DR Processing & Review Workstation by GE Medical Systems Israel, Functional Imaging — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00840682134897 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED be8f4634-fa9f-4810-b108-3e3c93593765 61 fields · synced Jun 18, 2026
- FDA UDI a1d91701-fe34-43d9-b6bf-531a522189cd 33 fields · synced May 30, 2026