TrackX

Interventional Fluoroscopic X-ray System

TrackX Technology, LLC

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

Pre-market Notification Details

• Device ID: K173736
• 510k Number: K173736
• Device Name: TrackX
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: TrackX Technology, LLC 5102 Durham Chapel Hill Blvd. Suite 203 Durham, NC 27707
• Contact: Calley Herzog
• Correspondent: Calley Herzog; Biologics Consulting Group, Inc. 1555 King St., Suite 300 Alexandria, VA 22314
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: LLZ
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-12-06
• Decision Date: 2018-02-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00857088008653	K173736	000
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