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OsiriX MD
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref OsiriX MD510(k) K101342
by Pixmeo SARL
Identity
- Trade Name
- OsiriX MD EUDAMED
- Device Name
- OsiriX MD EUDAMED
- Model / Reference
- OsiriX MD EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-7649990819013GP EUDAMED
- Basic UDI-DI
- B-7649990819013GP EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY 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
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
OsiriX MD by Pixmeo Sàrl — Class IIa — FDA_510K, MDD — listed in EUDAMED, 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 | K101342 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-7649990819013GP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pixmeo SARL
- EUDAMED SRN
- CH-MF-000037624
- Authorised Representative
- Opale FR-AR-000037417
Sources (2)
- EUDAMED e88f1ce7-5f63-4699-bbd8-90b7f7ade77c 85 fields · synced Jun 18, 2026
- FDA 510(k) K101342 1 fields · synced May 18, 2026