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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 K182395
Device Name OARtrac System
Applicant
RadialDyne, LLC
10801 Hammerly Blvd. Suite 220
Houston,  TX  77043
Applicant Contact John Isham
Correspondent
The Allis Law Firm, PLLC
2437 Bay Area Blvd., #30
Houston,  TX  77058
Correspondent Contact Carmelina G. Allis
Regulation Number892.5050
Classification Product Code
NZT  
Date Received09/04/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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