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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 K200360
Device Name TrackX
Applicant
Track X Technology, LLC
200 Timberhill Place, Suite 223
Chapel Hill,  NC  27514
Applicant Contact David Skwerer
Correspondent
Biologics Consulting
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 Received02/13/2020
Decision Date 03/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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