Cleared Traditional

Venue Sprint

K240206 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Jun 2024
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K240206 is an FDA 510(k) clearance for the 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 (Wauwatosa, US). The FDA issued a Cleared decision on June 10, 2024, 137 days after receiving the submission on January 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K240206 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2024
Decision Date June 10, 2024
Days to Decision 137 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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