510(k) K023100

ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS by General Electric Medical Systems Information Techn — Product Code LLZ

K023100 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.