510(k) K122613 ยท LNH System, Nuclear Magnetic Resonance Imaging
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | Aug 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122613
| 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. Vantage Titan, Model: MRT-1504 Open, Classified |
LNH | None listed |
| May 21, 2021 | Canon Medical System, USA, INC. Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.