510(k) K230355 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Aug 30, 2023 |
| Received | Feb 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2026 | Canon Medical System, USA, INC. VANTAGE GALAN 3T
Model MRT-3020/MEXL-3020 Open, Classified |
LNH | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.