Mindray Medical International Limited, a developer, manufacturer and marketer of medical devices, has received 510(k) clearance from the FDA for its DC-3 color ultrasound imaging system.
The clearance comes in addition to China State FDA approval and CE Mark granted earlier this year for the sale of the DC-3 in Chinese and European markets, respectively, according to the Shenzhen, China-based company.
The compact DC-3 combines 2D imaging and exceptional color Doppler performance, according to Li Xiting, Mindray's president and co-CEO.
Mindray said its DC-3 color ultrasound imaging system is designed to have applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets. The product is suited for U.S. hospitals, doctors' offices and veterinary clinics seeking to replace black and white ultrasound imaging systems.