Digimamo D— 510(k) K210151

Substantially Equivalent

Vmi Tecnologias Ltda

FDA 510(k) clearance K210151 for Digimamo D, Substantially Equivalent on 2022-03-01. Applicant: Vmi Tecnologias Ltda.

Clearance details

Applicant: Vmi Tecnologias Ltda
Product code: Code MUE
Advisory panel: Radiology
Date received: 2021-01-21
Decision date: 2022-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lagoa Santa, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.