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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 Triage And Notification Software
510(k) Number K203260
Device Name syngo.CT Brain Hemorrhage
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Applicant Contact Tabitha Estes
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Correspondent Contact Tabitha Estes
Regulation Number892.2080
Classification Product Code
QAS  
Date Received11/05/2020
Decision Date 01/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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