MOONRAY MOBILE C-ARM— 510(k) K013426

Substantially Equivalent

Simad S.R.L.

FDA 510(k) clearance K013426 for MOONRAY MOBILE C-ARM, Substantially Equivalent on 2002-03-26. Applicant: Simad S.R.L..

Clearance details

Applicant: Simad S.R.L.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2001-10-16
Decision date: 2002-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, OH, 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.