Cleared Traditional

Vivid E80, Vivid E90, Vivid E95

K173341 · GE Medical Systems · Radiology
Nov 2017
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K173341 is an FDA 510(k) clearance for the Vivid E80, Vivid E90, Vivid E95, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems (Wauwatosa, US). The FDA issued a Cleared decision on November 2, 2017, 9 days after receiving the submission on October 24, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K173341 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2017
Decision Date November 02, 2017
Days to Decision 9 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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