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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 K232431
Device Name syngo.CT Brain Hemorrhage
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Monsuru Bello
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Monsuru Bello
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/11/2023
Decision Date 03/22/2024
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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