TrackX

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 ID: K200360
• 510k Number: K200360
• Device Name: TrackX
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Track X Technology, LLC 200 Timberhill Place, Suite 223 Chapel Hill, NC 27514
• Contact: David Skwerer
• Correspondent: Calley Herzog; Biologics Consulting 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-13
• Decision Date: 2020-03-05