510(k) K172695 ยท MOS Coil, Magnetic Resonance, Specialty
AIR Anterior Array, AIR Posterior Array
| Applicant | Ge Healthcare Coils (Usa Instruments, Inc.), Aurora OH, US |
| Decision | Substantially Equivalent, Nov 22, 2017 |
| Received | Sep 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2019 | GE Healthcare, LLC AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems. Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.