Cleared Traditional

FUJIFILM SonoSite iViz Ultrasound System

K152983 · FUJIFILM Sonosite, Inc. · Radiology
Nov 2015
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K152983 is an FDA 510(k) clearance for the FUJIFILM 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 November 12, 2015, 34 days after receiving the submission on October 9, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K152983 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2015
Decision Date November 12, 2015
Days to Decision 34 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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