Cleared Traditional

Venue

K170714 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Jun 2017
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K170714 is an FDA 510(k) clearance for the Venue, 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 June 21, 2017, 104 days after receiving the submission on March 9, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K170714 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2017
Decision Date June 21, 2017
Days to Decision 104 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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