Mindray Medical International Limited (NYSE:MR), a leading developer, manufacturer and marketer of medical devices worldwide, today announced it has received 510(k) clearance from the United States Food and Drug Administration ("FDA") for its DC-3 color ultrasound imaging system. The clearance comes in addition to China State Food and Drug Administration ("SFDA") approval and CE Mark granted earlier this year for the sale of the DC-3 in Chinese and European markets, respectively.
"The compact DC-3 combines outstanding 2D imaging and exceptional color Doppler performance," said Mr. Li Xiting, Mindray's president and co-chief executive officer. "With a superior price-to-performance ratio, we are confident that this versatile product will meet the diverse needs and requirements of hospitals, doctors' offices and veterinary clinics around the world."
The DC-3 color ultrasound imaging system is designed to have extensive applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets. The product is ideally suited for US hospitals, doctors' offices and veterinary clinics seeking to replace black and white ultrasound imaging systems. The DC-3 is tailored to expand Mindray's customer base in low-end markets and complements the company's FDA-approved DC-6 and portable M5 ultrasound imaging systems, which are targeted for middle and high-end markets and received FDA 510(k) clearance in September, 2006 and March, 2008, respectively. The company currently offers over 10 medical imaging products of which five have received FDA 510(k) clearance.
Mindray has to date received FDA 510(k) clearance for a total of 16 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems.
