K254075
- 510(k) number
- K254075
- Device name
- Synapse Lung Nodule AI
- Applicant
- Fujifilm Corporation JP
- Product code
- OEB — Lung Computed Tomography System, Computer-Aided Dete
- Decision date
- 2026-05-27
- Date received
- 2025-12-18
- 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: K254075.pdf
Official FDA record: K254075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.