K261170
- 510(k) number
- K261170
- Device name
- BA-004CC
- Applicant
- Fujifilm Corporation JP
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2026-08-12
- Date received
- 2026-04-09
- 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: K261170.pdf
Official FDA record: K261170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.