510(k) K160518 ยท JAI Couch, Radiation Therapy, Powered
LEONI ORION System
| Applicant | Leoni Cia Cable System, Chartres, FR |
| Decision | Substantially Equivalent, Jul 14, 2016 |
| Received | Feb 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160518
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2023 | LEONI CIA CABLE SYSTEMS ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment.
Part Numbe Open, Classified |
JAI | None listed |
| Nov 21, 2023 | LEONI CIA CABLE SYSTEMS ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment.
Part Numbe Open, Classified |
JAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.