SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING


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

Correspodent Contact allison manners
Regulation Number 892.5050
Classification Product Code
MUJ  
Subsequent Product Code
LLZ  
Date Received 05/10/2011
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