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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 Prioritization Software For Lesions
510(k) Number K183182
Device Name Critical Care Suite
Applicant
GE Medical Systems, LLC.
3000 N. Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Camille Vidal
Correspondent
GE Medical Systems, LLC.
3000 N. Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Camille Vidal
Regulation Number892.2080
Classification Product Code
QFM  
Date Received11/19/2018
Decision Date 08/12/2019
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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