K253448
- 510(k) number
- K253448
- Device name
- Sonosite MT Ultrasound System
- Applicant
- FUJIFILM Sonosite, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-11-03
- Date received
- 2025-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253448.pdf
Official FDA record: K253448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.