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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K173736
Device Name TrackX
Applicant
Track X Technology, LLC
5102 Durham Chapel Hill Blvd.
Suite 203
Durham,  NC  27707
Applicant Contact Calley Herzog
Correspondent
Biologics Consulting Group, Inc.
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   LLZ  
Date Received12/06/2017
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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