K233597
- 510(k) number
- K233597
- Device name
- Sonosite LX Ultrasound System
- Applicant
- FUJIFILM Sonosite, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-12-06
- Date received
- 2023-11-08
- 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: K233597.pdf
Official FDA record: K233597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.