Cleared Traditional

SonoSite SII Ultrasound System

K160734 · FUJIFILM Sonosite, Inc. · Radiology
Apr 2016
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K160734 is an FDA 510(k) clearance for the SonoSite SII 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 April 5, 2016, 19 days after receiving the submission on March 17, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K160734 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2016
Decision Date April 05, 2016
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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