EchoPAC Software Only / EchoPAC Plug-in

GE Medical Systems Ultrasound and Primary Care Diagnostics · K251342 · 2025-07-16

EchoPAC Software Only / EchoPAC Plug-in is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary Care Diagnostics, listed by FDA (510(k), K251342) with a decision date of 2025-07-16. Review panel: Radiology.

FDA submission numberK251342
Pathway510(k)
CompanyGE Medical Systems Ultrasound and Primary Care Diagnostics
Review panel (specialty)Radiology
FDA decision date2025-07-16
DecisionSubstantially Equivalent
Product codeQIH
ClassificationAutomated Radiological Image Processing Software
Device class2
Regulation number892.2050
Review time (calendar days)77
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.