510(k) K243335 ยท LNH System, Nuclear Magnetic Resonance Imaging
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jan 7, 2025 |
| Received | Oct 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Canon Medical System, USA, INC. VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.