510(k) K032541 ยท LNH System, Nuclear Magnetic Resonance Imaging
POLESTAR N-20
| Applicant | Odin Medical Technologies , Ltd., Yokneam Elit, IL |
| Decision | Substantially Equivalent, Sep 12, 2003 |
| Received | Aug 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032541
| 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 |
| Aug 19, 2010 | Odin Medical Technologies Ltd. PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063,
Usage: Low field MRI device used to gather cranial images. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.