510(k) K171778 ยท LNH System, Nuclear Magnetic Resonance Imaging
MR Wireless Gating System, Model WGS-100
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Mar 14, 2018 |
| Received | Jun 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171778
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.