K233629
- 510(k) number
- K233629
- Device name
- APERTO Lucent MRI System
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-05-10
- Date received
- 2023-11-13
- 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: K233629.pdf
Official FDA record: K233629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.