Medical Devices

Koning Breast CT - P130025

Image of the device.This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Koning Breast CT (CBCT 1000)
PMA Applicant: Koning Corporation
Address: 150 Lucius Gordon Drive Suite 112, West Henrietta, NY 14586
Approval Date: January 14, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130025a.pdf

What is it? The Koning Breast CT (KBCT) system is a dedicated breast imaging system that acquires computed tomography (CT) images without compressing the breast. The KBCT produces 3D images to aid in the diagnosis of breast cancer.

How does it work? 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 3D images of the entire breast.

When is it used? 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.

What will it accomplish? The 3D 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.

When should it not be used? There are no known contraindications.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

Page Last Updated: 02/09/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English