510(k) K093044 ยท LNI System, Nuclear Magnetic Resonance Spectroscopic
OASIS MRI SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Mar 16, 2010 |
| Received | Sep 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093044
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2018 | Hitachi Medical Systems America Inc Hitachi Oasis MRI system
Product Usage:
Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and withou Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.