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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 K990071
Device Name IMAGEFUSION 2.0
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Applicant Contact NANCY C MACDONALD
Correspondent
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON,  MA  01803 -2516
Correspondent Contact NANCY C MACDONALD
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/11/1999
Decision Date 02/08/1999
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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