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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name full field digital, system, x-ray, mammographic
510(k) Number K210151
Device Name Digimamo D
Applicant
VMI Tecnologias LTDA
Rua Prefeito Elizeu Alves Da Silva, 400 - Dist. Ind. Genesco
Aparecido De Oliveira
Lagoa Santa,  BR
Applicant Contact Siele Santos
Correspondent
Kamm and Associates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1715
Classification Product Code
MUE  
Date Received01/21/2021
Decision Date 03/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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