FDA 510(k)

Sonosite iLOOK Ultrasound System

Numéro K : K260595 · 2026-03-10

Date de décision2026-03-10

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Sonosite iLOOK Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K260595. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K260595.

When did Sonosite iLOOK Ultrasound System receive FDA 510(k) clearance?

Sonosite iLOOK Ultrasound System received FDA 510(k) clearance on 2026-03-10, under 510(k) number K260595.

Who is the listed applicant for Sonosite iLOOK Ultrasound System?

The FDA 510(k) record lists FUJIFILM Sonosite, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonosite iLOOK Ultrasound System?

The FDA product code for Sonosite iLOOK Ultrasound System is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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