510(k) K203553 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Feb 2, 2021 |
| Received | Dec 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2021 | Canon Medical System, USA, INC. Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic struct Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.