510(k) K092308 ยท LNH System, Nuclear Magnetic Resonance Imaging
POLESTAR, MODEL N-30
| Applicant | Medtronic Navigation Israel, Ltd., Yokneam Elit, IL |
| Decision | Substantially Equivalent, Mar 16, 2010 |
| Received | Jul 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092308
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2016 | Medtronic Navigation PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller
Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging d Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.