Cleared Traditional

ControlRad Trace Model 9

K200663 · Controlrad, Inc. · Radiology

Jun 2020

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K200663 is an FDA 510(k) clearance for the 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 June 24, 2020, 103 days after receiving the submission on March 13, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K200663 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2020
Decision Date	June 24, 2020
Days to Decision	103 days
Submission Type	Traditional
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