Voluson Signature 20, Voluson Signature 18

GE Medical Systems Ultrasound and Primary care Diagnostics, · K233692 · 2024-03-07

Voluson Signature 20, Voluson Signature 18 is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary care Diagnostics,, listed by FDA (510(k), K233692) with a decision date of 2024-03-07. Review panel: Radiology.

FDA submission numberK233692
Pathway510(k)
CompanyGE Medical Systems Ultrasound and Primary care Diagnostics,
Review panel (specialty)Radiology
FDA decision date2024-03-07
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)111
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.