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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dosimeter, Ionizing Radiation, Implanted
510(k) Number K162954
Device Name OARtrac System with Patient Specific Reusable Universal PSD Sensors
Applicant
RADIADYNE, LLC
10801 HAMMERLY BLVD., SUITE 220
HOUSTON,  TX  77043
Applicant Contact JOHN K. ISHAM
Correspondent
EMERGO GROUP
2500 BEE CAVE ROAD, BLDG. 1, SUITE 300
AUSTIN,  TX  78746
Correspondent Contact STUART R. GOLDMAN
Regulation Number892.5050
Classification Product Code
NZT  
Date Received10/24/2016
Decision Date 06/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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