March 4, 2015 — The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) market clearance for the Koning Breast CT (KBCT 1000). It is a dedicated breast imaging system that acquires computed tomography (CT) images without compressing the breast. The KBCT produces 3-D images to aid in the diagnosis of breast cancer.
The patient lies face down on a table that is mounted above the KBCT hardware. The table has an opening to allow one breast to hang through it. In less than 10 seconds, the KBCT hardware rotates around the breast without compressing it. The KBCT acquires data that is used by the software to reconstruct cross-sectional 3-D images of the entire breast.
The FDA said the KBCT is intended for breast cancer diagnosis in women who have suspicious signs or symptoms of breast cancer, or who have abnormal imaging findings, and who need more imaging tests to determine whether a biopsy should be performed. KBCT images should be read by a physician along with standard screening mammograms. The KBCT is not intended for breast cancer screening.
It provides 3-D images of the entire breast provide additional information to help physicians determine if any of the patient's clinical or imaging abnormalities may be breast cancer
For more information: www.fda.gov