K241429
- 510(k) number
- K241429
- Device name
- ECHELON Synergy MRI System
- Applicant
- Fujifilm Healthcare Corporation JP
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-08-13
- Date received
- 2024-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K241429.pdf
Official FDA record: K241429
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.