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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K193294
Device Name AI-Rad Companion Engine
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-3
Malvern,  PA  19355
Applicant Contact Lauren Bentley
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-3
Malvern,  PA  19355
Correspondent Contact Lauren Bentley
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/27/2019
Decision Date 07/10/2020
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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