510(k) K193097 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jul 14, 2020 |
| Received | Nov 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193097
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.