MEDVOXEL HEARTPRO SOFTWARE APPLICATION


Device Classification Name

system, image processing, radiological

510(k) Number K103565
Device Name MEDVOXEL HEARTPRO SOFTWARE APPLICATION
Applicant
MEDVOXEL SYSTEMS INC
2867 crosscurrent drive
mississauga, 

CA

l5n 6l1

Applicant Contact bonnie sewlochan
Correspondent
MEDVOXEL SYSTEMS INC
2867 crosscurrent drive
mississauga, 

CA

l5n 6l1

Correspodent Contact bonnie sewlochan
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/06/2010
Decision Date 04/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No