Frequently Asked Questions

Koning Breast CT provides isotropically accurate images of the breast, allowing for the detection of early stage cancers with NO BREAST COMPRESSION. The Koning device provides diagnostic and biopsy-guided exams with and without the use of contrast.

KBCT machines are made in the USA.

Radiation dose of Koning Breast CT was measured to be in the same range as diagnostic mammograms. KBCT biopsy imaging dose was measured as a 50% reduction when compared to stereotactic biopsies.

Read more here:

https://pubmed.ncbi.nlm.nih.gov/22439131/

https://www.researchgate.net/publication/312853625_Initial_Experience_with_a_Cone-beam_Breast_Computed_Tomography-guided_Biopsy_System

After rigorous study, Koning Breast CT obtained FDA PMA approval for both breast CT and 3D-guided biopsy. This is the highest bar of approval for the FDA.

Read more here: 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130025

Effective 1/2021, the American Medical Association provided Breast CT with 6 dedicated CPT codes. The codes are now being accepted by both public and private payers. 

Surveys have shown the majority of women who receive mammograms consider the experience to be painful due to compression. Unfortunately, all mammograms require rigorous breast compression which is the only way for 2-dimensional mammography X-rays to penetrate the breast tissue.

Additional surveys have shown, pain from compression leads many women to forego the recommendations to obtain an annual mammogram. Not complying with the recommendations often results in late-stage cancer diagnoses where treatment outcomes are not as promising in comparison to cancer found earlier.

Breast CT, “KBCT”, is the first X-ray-based breast imaging device that does not require painful compression and produces a true 3-dimensional image of the breast at the same dose as a 2-dimensional compressional mammogram and the exam time is a rapid 7 seconds per breast. Koning believes the vast majority of women will find this a welcome improvement from mammography and Breast CT should have a positive impact on those currently not complying with the recommendations.

Read more here:

https://www.jpsmjournal.com/article/S0885-3924(02)00598-5/pdf

Compressional DBT has been marketed as 3D when, in fact, it is not true 3D. For an image to be true 3D it must be "isotropic" (the same from any angle). Breast CT is true 3D - the image can be viewed from any angle equally, which eliminates any overlapping structures. It acquires true 3D images without compression.

By the end of 2020, KBCT was already installed in 20 facilities globally.

At this time, KBCT is in clinical use in Rochester, NY and Knoxville, TN.

Find a location near you:

http://archive.koninghealth.com/contact-us/find-a-center 

We believe the screening indication is the most important project currently in the product plan. The clinical trial is underway and the anticipated timing for a screening indication is by end of 2023 or the beginning of 2024.

The clinical trial has been registered on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT05036096

Over 130 papers have been published on the technology. Please visit http://archive.koninghealth.com/news-insights/publications for access to the papers.

1. Breast CT is an efficient (7 second) breast imaging device that obtains a low dose, isotropic, 360° image of the breast. This allows radiologists to see the condition of the breast from multiple angles and in a true 3-dimensional image without multiple requests for additional views.
2. Patients will no longer endure the discomfort from compression and the patient with implants will no longer be required to receive double the pictures which means double the dose to the breast tissue.
3. Breast CT produces one 360° image of the breast, and the patient is done.

• Unilateral or bi-lateral imaging of the breast with or without contrast.
• X-ray guided 3-dimensionally targeted biopsy
• Contrast-enhanced imaging when indicated
• Breast implant imaging without displacement views
• Neoadjuvant therapy monitoring imaging