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Tripath Imaging
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VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) is an FDA 510(k)-cleared medical device (K061613) manufactured by Tripath Imaging. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2007. Regulation: 8.