Cleared Traditional

ControlRad Trace Model 8

K183109 · Controlrad, Inc. · Radiology

May 2019

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K183109 is an FDA 510(k) clearance for the ControlRad Trace Model 8, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Controlrad, Inc. (Radnor, US). The FDA issued a Cleared decision on May 13, 2019, 186 days after receiving the submission on November 8, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K183109 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2018
Decision Date	May 13, 2019
Days to Decision	186 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