K251830
- 510(k) number
- K251830
- Device name
- Sonosite LX Ultrasound System
- Applicant
- FUJIFILM Sonosite, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-07-10
- Date received
- 2025-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251830.pdf
Official FDA record: K251830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.