Interventional Fluoroscopic X-ray System

Track X Technology, LLC

The following data is part of a premarket notification filed by Track X Technology, Llc with the FDA for Trackx.

Pre-market Notification Details

Device IDK200360
510k NumberK200360
Device Name:TrackX
ClassificationInterventional Fluoroscopic X-ray System
Applicant Track X Technology, LLC 200 Timberhill Place, Suite 223 Chapel Hill,  NC  27514
ContactDavid Skwerer
CorrespondentCalley Herzog
Biologics Consulting 1555 King St., Suite 300 Alexandria,  VA  22314
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeLLZ
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-13
Decision Date2020-03-05

© 2020
This site is not affiliated with or endorsed by the FDA.