510(k) K191128 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Titan 3T, MRT-3010, V2.5
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jun 26, 2019 |
| Received | Apr 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2026 | Canon Medical System, USA, INC. VANTAGE TITAN 3T
Model MRT-3010/MEXL-3010 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.