FDA 510(k) Application Details - K210151

Device Classification Name	Full Field Digital,System,X-Ray,Mammographic   More FDA Info for this Device
510(K) Number	K210151
Device Name	Full Field Digital,System,X-Ray,Mammographic
Applicant	VMI Tecnologias LTDA Rua Prefeito Elizeu Alves Da Silva, 400 - Dist. Ind. Genesco Aparecido De Oliveira Lagoa Santa BR Other 510(k) Applications for this Company
Contact	Siele Santos Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MUE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2021
Decision Date	03/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review