Mindray's DC-3 Color Ultrasound Gains U.S. FDA 510(k) Clearance
06 Giugno 2008 - 12:00PM
PR Newswire (US)
SHENZHEN, China, June 6 /Xinhua-PRNewswire/ -- 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 U.S. 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. About Mindray Mindray Medical
International Limited is a leading developer, manufacturer and
marketer of medical devices worldwide. Established in 1991, Mindray
offers a broad range of products across three primary business
segments: patient monitoring & life support products, in-vitro
diagnostic products and medical imaging systems. Mindray is
globally headquartered in Shenzhen, China, with U.S. headquarters
in Mahwah, New Jersey. Mindray also has sales and service offices
internationally in Amsterdam, Istanbul, London, Mexico City,
Moscow, Mumbai, Sao Paulo, Seattle, Toronto and Vancouver. For more
information, please visit http://www.mindray.com/ . For investor
inquiries please contact: In China: Susan Du Mindray Medical
International Limited Tel: +86-755-2658-2518 Email: Justin Knapp
Ogilvy Public Relations Worldwide, Beijing Tel: +86-10-8520-6556
Email: In the United States: Jeremy Bridgman Ogilvy Public
Relations Worldwide, New York Tel: +1-212-880-5363 DATASOURCE:
Mindray Medical International Limited CONTACT: In China: Susan Du
of Mindray Medical International Limited, +86-755-2658-2518, or ;
or Justin Knapp of Ogilvy Public Relations Worldwide, Beijing,
+86-10-8520-6556, or ; or In the United States: Jeremy Bridgman of
Ogilvy Public Relations Worldwide, New York, +1-212-880-5363 Web
site: http://www.mindray.com/
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