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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 AVENUE
BURLINGTON,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
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
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