
Ventana Medical Systems, Inc.
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Virtuoso System for IHC PR (1E2) using iScan HT is an FDA 510(k)-cleared medical device (K142965) manufactured by Ventana Medical Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2015. Regulation: 8.