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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 K193283
Device Name AI-Rad Companion Prostate MR
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
QIH  
Subsequent Product Code
LNH  
Date Received11/27/2019
Decision Date 07/30/2020
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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