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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 K243145
Device Name syngo.CT LVO Detection
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Applicant Contact Kenny M. Bello
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
Correspondent Contact Kenny M. Bello
Regulation Number892.2080
Classification Product Code
QAS  
Date Received09/30/2024
Decision Date 04/10/2025
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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