Cleared Traditional

FUJIFILM Sonosite Vevo MD Imaging System

K190476 · FUJIFILM Sonosite, Inc. · Radiology
Mar 2019
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K190476 is an FDA 510(k) clearance for the FUJIFILM Sonosite Vevo MD Imaging 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 March 15, 2019, 16 days after receiving the submission on February 27, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K190476 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2019
Decision Date March 15, 2019
Days to Decision 16 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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