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 Number | 892.1715
|
Classification Product Code |
|
Date Received | 01/21/2021 |
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
|
|
|