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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K111642
Device Name ONCO TRAC MODEL 1, 2, 4
Applicant
Translational Sciences Corporation
One Mifflin Place
Suite 400
Cambridge,  MA  02138
Applicant Contact ALLEN GREEN, MD, PHD, JD
Correspondent
Translational Sciences Corporation
One Mifflin Place
Suite 400
Cambridge,  MA  02138
Correspondent Contact ALLEN GREEN, MD, PHD, JD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/13/2011
Decision Date 11/18/2011
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
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