K243762
- 510(k) number
- K243762
- Device name
- Synapse 3D Base Tools (V7.0)
- Applicant
- Fujifilm Corporation JP
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-05-21
- Date received
- 2024-12-06
- 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: K243762.pdf
Official FDA record: K243762
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.