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General Electric Medical Systems Information Techn
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ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS is an FDA 510(k)-cleared medical device (K023100) manufactured by General Electric Medical Systems Information Techn. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2002. Regulation: 8.