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

Pre-market Notification Details

Device IDK211782
510k NumberK211782
Device Name:ControlRad Select Model Z, ControlRad Trace Model 8, 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 CodeIZI
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-09
Decision Date2021-07-01

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