Cleared Abbreviated

SonoSite iViz Ultrasound System

K162288 · FUJIFILM Sonosite, Inc. · Radiology
Sep 2016
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K162288 is an FDA 510(k) clearance for the SonoSite iViz 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 September 8, 2016, 24 days after receiving the submission on August 15, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K162288 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2016
Decision Date September 08, 2016
Days to Decision 24 days
Submission Type Abbreviated
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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