Cleared Traditional

Vivid T8, Vivid T9

K181934 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Nov 2018
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K181934 is an FDA 510(k) clearance for the Vivid T8, Vivid T9, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on November 6, 2018, 110 days after receiving the submission on July 19, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K181934 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2018
Decision Date November 06, 2018
Days to Decision 110 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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