Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

GE Medical Systems Ultrasound and Primary Care Diagnostics, · K231965 · 2023-10-30

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary Care Diagnostics,, listed by FDA (510(k), K231965) with a decision date of 2023-10-30. Review panel: Radiology.

FDA submission numberK231965
Pathway510(k)
CompanyGE Medical Systems Ultrasound and Primary Care Diagnostics,
Review panel (specialty)Radiology
FDA decision date2023-10-30
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)119
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.