FDA OKs Mindray US scanner

Medical device manufacturer Mindray Medical International of Shenzhen, China, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its DC-3 color ultrasound system.

DC-3 is designed for abdominal, ob/gyn, endovaginal, cardiac, small parts, and pediatric applications in hospitals, physicians' offices, and veterinary clinics.

The system already has achieved clearance from China's State Food and Drug Administration and has received the CE Mark for marketing in Europe.

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