510(k) K172878 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Titan 3T, MRT-3010/A7, M-Power GX
| Applicant | Toshiba Medical Systems Corporation, Japan, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Nov 17, 2017 |
| Received | Sep 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2021 | Canon Medical System, USA, INC. Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique image Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.