AQUILA 320 D / AQUILA 320 S— 510(k) K201340

Name: FDA 510(k) clearance K201340
Creator: U.S. Food and Drug Administration
Published: 2020-06-19

Substantially Equivalent

Vmi Tecnologias Ltda

FDA 510(k) clearance K201340 for AQUILA 320 D / AQUILA 320 S, Substantially Equivalent on 2020-06-19. Applicant: Vmi Tecnologias Ltda. Device class: 2.

Clearance details

Applicant: Vmi Tecnologias Ltda
Product code: Code IZL
Device class: Class 2
Regulation: 21 CFR 892.1720
Advisory panel: Radiology
Date received: 2020-05-20
Decision date: 2020-06-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Aparecido De Oliveira, Lagoa Santa, BR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.