K231666
- 510(k) number
- K231666
- Device name
- Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2023-12-13
- Date received
- 2023-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231666.pdf
Official FDA record: K231666
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.