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
00860099000899	K173736	000
00857088008165	K173736	000
00857088008257	K173736	000
00857088008219	K173736	000
00857088008530	K173736	000
00857088008547	K173736	000
00857088008608	K173736	000
00857088008585	K173736	000
00857088008523	K173736	000
00857088008486	K173736	000
00857088008479	K173736	000
00857088008462	K173736	000
00857088008455	K173736	000
00857088008561	K173736	000
00857088008677	K173736	000
00857088008554	K173736	000
00857088008615	K173736	000
00857088008646	K173736	000
00857088008172	K173736	000
00857088008417	K173736	000
00857088008424	K173736	000
00860099000837	K173736	000
00860099000813	K173736	000
00860099000806	K173736	000
00857088008066	K173736	000
00857088008035	K173736	000
00857088008028	K173736	000
00857088008011	K173736	000
00857088008004	K173736	000
00857088008233	K173736	000
00857088008226	K173736	000
00857088008202	K173736	000
00857088008196	K173736	000
00857088008134	K173736	000
00857088008103	K173736	000
00857088008097	K173736	000
00857088008318	K173736	000
00857088008295	K173736	000
00857088008653	K173736	000