K250883
- 510(k) number
- K250883
- Device name
- ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2025-09-18
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250883.pdf
Official FDA record: K250883
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.