Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

GE Medical Systems, LLC · K223491 · 2023-05-25

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is an AI-enabled medical device from GE Medical Systems, LLC, listed by FDA (510(k), K223491) with a decision date of 2023-05-25. Review panel: Radiology.

FDA submission numberK223491
Pathway510(k)
CompanyGE Medical Systems, LLC
Review panel (specialty)Radiology
FDA decision date2023-05-25
DecisionSubstantially Equivalent
Product codeQBS
ClassificationRadiological Computer Assisted Detection/Diagnosis Software For Fracture
Device class2
Regulation number892.2090
Review time (calendar days)185
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.