510(k) K162001 ยท MOS Coil, Magnetic Resonance, Specialty
1.5T and 3.0T 16 CH GE Shoulder Coils
| Applicant | Invivo Corporation, Florida FL, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | Jul 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162001
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2020 | Invivo Corporation MR Coils
The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.