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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K060314
Device Name ROTATING GAMMA SYSTEM. GAMMA ART-6000
Applicant
American Radiosurgery, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Applicant Contact DAN OLIVIER
Correspondent
American Radiosurgery, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Correspondent Contact DAN OLIVIER
Regulation Number892.5750
Classification Product Code
IWB  
Date Received02/08/2006
Decision Date 04/06/2006
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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