Technology | March 04, 2015

System produces 3-D CT images to aid in breast cancer diagnosis

Koning Breast CT 1000, KBCT, computed tomography, mammography, FDA

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


Related Content

News | Artificial Intelligence

February 29, 2024 — AIxSCAN, Inc., a Sunnyvale, CA-based developer of a next generation artificial intelligence (AI) ...

Time February 29, 2024
arrow
News | Artificial Intelligence

February 28, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered solutions that enable medical providers ...

Time February 28, 2024
arrow
News | Artificial Intelligence

February 27, 2024 — Median Technologies announced that the Company will be participating and speaking at the premier ...

Time February 27, 2024
arrow
News | X-Ray

February 26, 2024 — AIxSCAN, Inc. began clinical trials in late 2023. The AIxSCAN, Inc. team is very pleased with the ...

Time February 26, 2024
arrow
News | Breast Imaging

February 23, 2024 — ScreenPoint Medical is showcasing its industry leading Transpara Breast AI at the 2024 European ...

Time February 23, 2024
arrow
News | Breast Imaging

February 22, 2024 — The FAST-Forward randomized trial from the UK found that ultrahypofractionated whole breast ...

Time February 22, 2024
arrow
News | Breast Imaging

February 20, 2024 — Annual breast cancer screening beginning at age 40 and continuing to at least age 79 results in the ...

Time February 20, 2024
arrow
News | FDA

February 15, 2024 — Merit Medical Systems, Inc., a global leader of healthcare technology, has received US Food and Drug ...

Time February 15, 2024
arrow
News | Breast Imaging

February 9, 2024 — An innovative breast imaging technique provides high sensitivity for detecting cancer while ...

Time February 09, 2024
arrow
Videos | RSNA

At RSNA23, Imaging Technology News (ITN) spoke with Bhvita Jani, principal analyst at Signify Research, about ...

Time February 07, 2024
arrow
Subscribe Now