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Iodp SA
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MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K011095) manufactured by Iodp SA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2001. Regulation: 8.