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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, Charged-Particle, Medical
510(k) Number K053280
Device Name PROBEAT
Applicant
Hitachi, Ltd., Power Systems Group
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN KAHAN
Correspondent
Hitachi, Ltd., Power Systems Group
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN KAHAN
Regulation Number892.5050
Classification Product Code
LHN  
Date Received11/23/2005
Decision Date 03/09/2006
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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