K241496
- 510(k) number
- K241496
- Device name
- Vantage Galan 3T, MRT-3020, 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
- 2024-08-20
- Date received
- 2024-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241496.pdf
Official FDA record: K241496
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.