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

Name: FDA 510(k) clearance K211782
Creator: U.S. Food and Drug Administration
Published: 2021-07-01

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.. Device class: 2.

Clearance details

Applicant: Controlrad, Inc.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
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 ↗

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More clearances from Controlrad, Inc.

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K213455 — ControlRad Select Model Z2021-11-24
K202431 — ControlRad Select Model Z2020-12-23
K200663 — ControlRad Trace Model 92020-06-24
K200238 — ControlRad Sterile Cover2020-04-26
K183109 — ControlRad Trace Model 82019-05-13

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.