Cleared Traditional

Venue; Venue Go; Venue Fit; Venue Sprint

K251322 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Jul 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K251322 is an FDA 510(k) clearance for the Venue; Venue Go; Venue Fit; Venue Sprint, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on July 25, 2025, 87 days after receiving the submission on April 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K251322 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2025
Decision Date July 25, 2025
Days to Decision 87 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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