Koning Receives China Food and Drug Administration Clearance

ROCHESTER, NY, Dec. 2, 2015 /PRNewswire/ -- Koning Corporation, a leading developer of advanced medical imaging systems, today announces clearance from the China Food and Drug Administration (CFDA) for their Koning Breast Computed Tomography (KBCT) system. This approval signals that KBCT has undergone and successfully completed all aspects of CFDA's rigorous approval process for medical devices.

The KBCT is the first commercially available three-dimensional (3D) breast CT scanner designed specifically to image the entire breast with a single scan. The device overcomes the current limitations in 2D diagnostic mammography, eliminating overlapping tissue concerns and finally addresses a common patient complaint – breast compression. Through the application of full coverage acquisition at dose levels similar to diagnostic mammography, breast tissue can be reviewed in multiple planes and in genuine 3D reformation.

"The KBCT represents a revolutionary advancement in breast cancer diagnosis. This CFDA approval is a major step forward for breast imaging and women's health care in China," said Ruola Ning, PhD, Koning's president and founder, a pioneer and leading expert in Cone Beam CT Technology and sole inventor of cone beam breast CT technology.

KBCT advantages:

• Image detail - Integrating cone beam CT technology into this dedicated breast imaging device results in excellent spatial and contrast resolution in multiple planes. Image of the uncompressed breast produces a spatially representative mode, allowing accurate measurement of breast tumor's size and volume as well as breast density.
• Comfortable prone positioning - KBCT image acquisition allows the patient to lie in a comfortable and natural prone position with minimal technologist manipulation of the breast tissue and without compression.
• Contrast enhanced breast CT imaging - KBCT can be used with or without contrast media, providing an alternative to MRI imaging for more accurate diagnosis and disease staging.

Studies
More than 400 Asian patients have been scanned on KBCT in China at Tianjin Medical University Cancer Institute and Hospital (Tianjin, China) and Sun Yat-Sen University Cancer Center (Guangzhou, China). A large reader study conducted at Tianjin Medical University Cancer Institute and Hospital proves that KBCT has significantly higher diagnostic accuracy than Diagnostic Mammography.

For more information visit: www.koningcorporation.com.

Contact Information
Benyu Chen
VP Sales and Marketing
(+86) 13301323666
benyu.chen@koningcorporation.com 

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