K250901
- 510(k) number
- K250901
- Device name
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-07-22
- Date received
- 2025-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250901.pdf
Official FDA record: K250901
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.