ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9— 510(k) K211782

Substantially Equivalent

Controlrad, Inc.

FDA 510(k) clearance K211782 for ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9, Substantially Equivalent on 2021-07-01. Applicant: Controlrad, Inc..

Clearance details

Applicant: Controlrad, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2021-06-09
Decision date: 2021-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, 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.