ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS


Device Classification Name

system, image processing, radiological

510(k) Number K023100
Device Name ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee, 
WI 
53223

Original Contact lisa lee michels
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/18/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No