LEONI ORION System
FDA 510(k) clearance K160518 · decided 2016-07-14
Clearance details
- K-number
- K160518
- Device name
- LEONI ORION System
- Applicant
- Leoni Cia Cable System
- Decision
- Substantially Equivalent
- Date received
- 2016-02-24
- Decision date
- 2016-07-14
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- JAI
- Device class
- 2
- Regulation number
- 892.5770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Chartres, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for pa recall (Z-0398-2024) | LEONI CIA CABLE SYSTEMS | 2023-11-21 |
| ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for pa recall (Z-0399-2024) | LEONI CIA CABLE SYSTEMS | 2023-11-21 |