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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K222172
Device Name MI View&GO
Applicant
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Applicant Contact Clayton Ginn
Correspondent
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville,  TN  37932
Correspondent Contact Clayton Ginn
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/21/2022
Decision Date 08/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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