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Pie Medical
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PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS is an FDA 510(k)-cleared medical device (K041675) manufactured by Pie Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2004. Regulation: 8.