Cleared Special

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

K211782 · Controlrad, Inc. · Radiology

Jul 2021

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K211782 is an FDA 510(k) clearance for the ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Controlrad, Inc. (Norcross, US). The FDA issued a Cleared decision on July 1, 2021, 22 days after receiving the submission on June 9, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K211782 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2021
Decision Date	July 01, 2021
Days to Decision	22 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy