VIRTUOST— 510(k) K113725

Substantially Equivalent

O.N. Diagnostics

FDA 510(k) clearance K113725 for VIRTUOST, Substantially Equivalent on 2012-09-13. Applicant: O.N. Diagnostics.

Clearance details

Applicant: O.N. Diagnostics
Product code: Code KGI
Advisory panel: Radiology
Date received: 2011-12-19
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

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Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.