Cleared Traditional

Venue Fit

K220848 · GE Medical Systems · Radiology
Jun 2022
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K220848 is an FDA 510(k) clearance for the Venue Fit, 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 June 27, 2022, 96 days after receiving the submission on March 23, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K220848 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2022
Decision Date June 27, 2022
Days to Decision 96 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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