510(k) K240465 ยท OWB Interventional Fluoroscopic X-Ray System
O-arm O2 Imaging System
| Applicant | Medtronic Navigation, Inc., Boxborough MA, US |
| Decision | Substantially Equivalent, Jun 21, 2024 |
| Received | Feb 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2026 | Medtronic Navigation, Inc.-Boxborough Medtronic O-arm O2 Imaging System. Model Number: BI70002000. Open, Classified |
OWB | None listed |
| Jul 9, 2025 | Medtronic Navigation, Inc.-Boxborough O-arm O2 Imaging System. Mobile X-Ray System. Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.