510(k) K222968 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Oct 25, 2022 |
| Received | Sep 27, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222968
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2024 | Canon Medical System, USA, INC. MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020) Open, Classified |
LNH | None listed |
| Mar 4, 2024 | Canon Medical System, USA, INC. MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.