K253862
- 510(k) number
- K253862
- Device name
- APERTO Lucent MRI System
- Applicant
- Fujifilm Corporation JP
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-04-06
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253862.pdf
Official FDA record: K253862
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.