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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K063230
Device Name INTEGRA RADIONICS IMAGEFUSION 3
Applicant
Integra Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
Integra Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received10/25/2006
Decision Date 12/21/2006
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
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