K231574
- 510(k) number
- K231574
- Device name
- Scenaria View 4.2
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-10-12
- Date received
- 2023-05-31
- 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: K231574.pdf
Official FDA record: K231574
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.