510(k) K170412 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Titan 1.5T, MRT-1510, M-Power GX
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Feb 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2021 | Canon Medical System, USA, INC. Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique im Open, Classified |
LNH | None listed |
| May 30, 2018 | Canon Medical System, USA, INC. Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anat Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.