Submission Details
| 510(k) Number | K260595 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2026 |
| Decision Date | March 10, 2026 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Sonosite iLOOK Ultrasound System
Mar 2026
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K260595 is an FDA 510(k) clearance for the Sonosite iLOOK Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on March 10, 2026, 15 days after receiving the submission on February 23, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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