Sonosite iLOOK Ultrasound System— 510(k) K260595
Substantially EquivalentFUJIFILM Sonosite, Inc.
FDA 510(k) clearance K260595 for Sonosite iLOOK Ultrasound System, Substantially Equivalent on 2026-03-10. Applicant: FUJIFILM Sonosite, Inc.. Device class: 2.
Summary
FUJIFILM Sonosite's Sonosite iLOOK Ultrasound System is filed under IYN, pulsed Doppler ultrasonic imaging systems. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1550. It was a Traditional 510(k), and Radiology is both the classification panel and the review panel.
FUJIFILM Sonosite filed from Bothell, Washington. The decision came 15 calendar days after FDA received it (February 23 to March 10, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- FUJIFILM Sonosite, Inc.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
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- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from FUJIFILM Sonosite, Inc.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.