Identity
- Trade Name
- O-Scan EUDAMEDFDA UDI
- Generic Name
- Extremity MRI system, permanent magnet FDA UDI
- Model / Reference
- 101003 EUDAMED101003000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304450081 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304450081 EUDAMED
- 510(k) Number
- K092469 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11050101 SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES) EUDAMED
- GMDN Term
- Extremity MRI system, permanent magnet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
O-Scan by Esaote S.p.A. — Class IIa — 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 | K183685 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304450081 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (3)
- EUDAMED 4d49eab4-5fab-46fe-b740-e1a4272f7845 61 fields · synced Aug 4, 2026
- FDA UDI 7f3dd818-cce0-4a62-bdee-80b929d0fc05 33 fields · synced May 29, 2026
- FDA 510(k) K183685 1 fields · synced May 18, 2026