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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
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