Cleared Traditional

Venue

K240111 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Jun 2024
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K240111 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 and Primary Care Diagnostics (Wauwatosa, US). The FDA issued a Cleared decision on June 10, 2024, 146 days after receiving the submission on January 16, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K240111 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2024
Decision Date June 10, 2024
Days to Decision 146 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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