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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K201340
Device Name AQUILA 320 D / AQUILA 320 S
Applicant
Vmi Tecnologias Ltda
Rua Prefeito Elizeu Alves Da Silva, 400 Dist. Ind. Genesco
Aparecido De Oliveira, Lagoa Santa,  BR 33400000
Applicant Contact Siele Santos
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received05/20/2020
Decision Date 06/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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