VERT-X— 510(k) K061873

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K061873 for VERT-X, Substantially Equivalent on 2006-08-18. Applicant: Direx Systems Corp..

Clearance details

Applicant: Direx Systems Corp.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2006-07-03
Decision date: 2006-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.