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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radiological computer assisted detection/diagnosis software for fracture
510(k) Number K223491
Device Name Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Chris Paulik
Correspondent
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Chris Paulik
Regulation Number892.2090
Classification Product Code
QBS  
Date Received11/21/2022
Decision Date 05/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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