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OSCAR 15(Unique FD)
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 107510(k) K172180
Identity
- Trade Name
- OSCAR 15(Unique FD) EUDAMEDGenoray FDA UDI
- Generic Name
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- OSCAR 15(Unique FD) EUDAMED
- Model / Reference
- 107 EUDAMEDOSCAR 15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244061219 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809244061219 EUDAMED
- 510(k) Number
- K172180 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDI
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
- GMDN Term
- Portable general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Greece 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
OSCAR 15(Unique FD) by Genoray Co., Ltd. — Class IIb — 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 | K172180 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809244061219 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 90aca641-901c-4feb-8ea4-7d1ee35160f1 85 fields · synced Jun 18, 2026
- FDA UDI d498267e-61a7-41dc-b7a5-0e402ac8d8a0 33 fields · synced May 30, 2026
- FDA 510(k) K172180 1 fields · synced May 18, 2026