Sonosite iLOOK Ultrasound System
K-Number: K260595 · 2026-03-10
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2026-03-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sonosite iLOOK Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2026-03-10 under approval number K260595. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sonosite iLOOK Ultrasound System?
Sonosite iLOOK Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K260595.
When was Sonosite iLOOK Ultrasound System approved by the FDA?
Sonosite iLOOK Ultrasound System received FDA 510(k) clearance on 2026-03-10, under approval number K260595.
What company makes Sonosite iLOOK Ultrasound System?
Sonosite iLOOK Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for Sonosite iLOOK Ultrasound System?
The FDA product code for Sonosite iLOOK Ultrasound System is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.