K251106
- 510(k) number
- K251106
- Device name
- Sonosite LX and Sonosite PX Ultrasound Systems
- Applicant
- FUJIFILM Sonosite, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-08-29
- Date received
- 2025-04-11
- 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: K251106.pdf
Official FDA record: K251106
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.