ControlRad Trace Model 8— 510(k) K183109

Substantially Equivalent

Controlrad, Inc.

FDA 510(k) clearance K183109 for ControlRad Trace Model 8, Substantially Equivalent on 2019-05-13. Applicant: Controlrad, Inc..

Clearance details

Applicant: Controlrad, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2018-11-08
Decision date: 2019-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Radnor, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.