ATLAS-BASED AUTOSEGMENTATION


Device Classification Name

system, radiation therapy, charged-particle, medical

510(k) Number K080799
Device Name ATLAS-BASED AUTOSEGMENTATION
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 corporate lake dr.
st. louis, 
MO 
63132 -1716

Applicant Contact kathryn stinson
Correspondent
COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 corporate lake dr.
st. louis, 
MO 
63132 -1716

Correspodent Contact kathryn stinson
Regulation Number 892.5050
Classification Product Code
LHN  
Subsequent Product Code
MUJ  
Date Received 03/21/2008
Decision Date 08/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No