CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE


Device Classification Name

system, image processing, radiological

510(k) Number K111373
Device Name CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
Applicant
CIRCLE CARDIOVASCULAR IMAGING INC.
#12, 3535 research road nw
calgary, ab, 

CA

t2l 2k8

Applicant Contact shirantha samarappuli
Correspondent
CIRCLE CARDIOVASCULAR IMAGING INC.
#12, 3535 research road nw
calgary, ab, 

CA

t2l 2k8

Correspodent Contact shirantha samarappuli
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/16/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No