K240571
- 510(k) number
- K240571
- Device name
- OASIS MRI System
- Applicant
- Fujifilm Healthcare Corporation JP
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-04-12
- Date received
- 2024-02-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240571.pdf
Official FDA record: K240571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.