ControlRad Trace Model 9

Interventional Fluoroscopic X-ray System

ControlRad, Inc.

The following data is part of a premarket notification filed by Controlrad, Inc. with the FDA for Controlrad Trace Model 9.

Pre-market Notification Details

Device IDK200663
510k NumberK200663
Device Name:ControlRad Trace Model 9
ClassificationInterventional Fluoroscopic X-ray System
Applicant ControlRad, Inc. 275 Scientific Drive NW #1100 Norcross,  GA  30092
ContactChris Fair
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock,  GA  30188
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-13
Decision Date2020-06-24

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