K223491

Substantially Equivalent

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

Applicant: Ge Medical Systems, LLC
Product code: QBS
Advisory panel: Radiology
Date received: 2022-11-21
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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