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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 Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K241770
Device Name Prostate MR AI (VA10A)
Applicant
Siemens Healthcare GmbH
Henkestr. 127
Erlanger,  DE 91052
Applicant Contact Abhineet Johri
Correspondent
Siemens Healthcare GmbH
Henkestr. 127
Erlanger,  DE 91052
Correspondent Contact Abhineet Johri
Classification Product Code
QDQ  
Date Received06/20/2024
Decision Date 03/05/2025
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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