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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 K112723
Device Name EPIGRAY
Applicant
Dosisoft SA
1244 Fairway Valley Ct.
Lincoln,  CA  95648
Applicant Contact ROBERT J MORTON
Correspondent
Doslsoft SA
1244 Fairway Valley Ct.
Lincoln,  CA  95648
Correspondent Contact ROBERT J MORTON
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/19/2011
Decision Date 02/08/2012
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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