K260595
- 510(k) number
- K260595
- Device name
- Sonosite iLOOK Ultrasound System
- Applicant
- FUJIFILM Sonosite, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-03-10
- Date received
- 2026-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260595.pdf
Official FDA record: K260595
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.