K240238
- 510(k) number
- K240238
- Device name
- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-04-12
- Date received
- 2024-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240238.pdf
Official FDA record: K240238
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.