K254189
- 510(k) number
- K254189
- Device name
- Synapse 3D Base Tools (V7.2)
- Applicant
- Fujifilm Corporation JP
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-04-30
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K254189.pdf
Official FDA record: K254189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.