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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 K111311
Device Name SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
Applicant
Omisa Inc. (Segasist Technologies)
1666 12th Line, Rr #3
Lakefield, Ontario,  CA K0L 2H0
Applicant Contact ALLISON MANNERS
Correspondent
Omisa Inc. (Segasist Technologies)
1666 12th Line, Rr #3
Lakefield, Ontario,  CA K0L 2H0
Correspondent Contact ALLISON MANNERS
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
LLZ  
Date Received05/10/2011
Decision Date 10/17/2011
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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