510(k) K202030 ยท LNH System, Nuclear Magnetic Resonance Imaging
OASIS MRI System
| Applicant | Hitachi Healthcare Americas, Twinsburg OH, US |
| Decision | Substantially Equivalent, Oct 21, 2020 |
| Received | Jul 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2021 | Hitachi Healthcare Americas Corporation OASIS MRI System Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.