510(k) K201340

AQUILA 320 D / AQUILA 320 S by Vmi Tecnologias Ltda — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2020
Date Received
May 20, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type