Mammography X-ray digital tomography equipment approved

On November 20, 2015, the State Food and Drug Administration approved the registration of medical devices for breast X-ray digital tomography equipment (model: KBCT-1000) of Corning (Tianjin) Medical Equipment Co., Ltd. The device consists of a control subsystem, a scanning subsystem and an operating subsystem. It is suitable for the diagnosis and differential diagnosis of breast diseases.

The mammography X-ray digital tomography apparatus (hereinafter referred to as breast CT) adopts cone beam X-ray and computed tomography, and is the first true three-dimensional breast imaging system in China. Breast CT solves the problem of breast tissue overlap in mammography, and can acquire CT images of the breast without squeezing the breast. The acquired images have the same spatial resolution on three axes, which can better detect the qualitative. Calcified clusters and their three-dimensional distribution can also be used to assess tumor angiogenesis.

The food and drug supervision and administration department will strengthen the supervision of products after listing and protect the safety of patients.