ControlRad Select Model Z

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.

Pre-market Notification Details

Device IDK202431
510k NumberK202431
Device Name:ControlRad Select Model Z
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
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2020-12-23

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