Venue; Venue Go; Venue Fit; Venue Sprint

GE Medical Systems Ultrasound and Primary care Diagnostics, · K251322 · 2025-07-25

Venue; Venue Go; Venue Fit; Venue Sprint is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary care Diagnostics,, listed by FDA (510(k), K251322) with a decision date of 2025-07-25. Review panel: Radiology.

FDA submission numberK251322
Pathway510(k)
CompanyGE Medical Systems Ultrasound and Primary care Diagnostics,
Review panel (specialty)Radiology
FDA decision date2025-07-25
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)87
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.