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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 K223363
Device Name MAMMOVISTA B.smart (VB70)
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Denise Adams
Correspondent
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Denise Adams
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/03/2022
Decision Date 01/12/2023
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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