No compression • 10-second scans per breast • True 3D isotropic imaging
Ideal for patients with dense breast tissue, implants, fear or discomfort with traditional mammography
No compression • 10-second scans per breast • True 3D isotropic imaging
Ideal for patients with dense breast tissue, implants, fear or discomfort with traditional mammography
Key advantages for providers:
Breast CT helps reduce diagnostic uncertainty when traditional mammography is limited. For appropriate patients, it supports clearer clinical decision-making, fewer inconclusive results, and efficient coordination of follow-up, without adding unnecessary burden to the referring practice.
Key advantages for providers:
3D Breast CT is a diagnostic alternative, not a replacement for traditional mammography, and is most useful in clearly defined clinical scenarios.
Prior mammography had abnormal or inconclusive findings and need further evaluation
Carry BRCA1/BRCA2 gene mutations or other genetic syndromes
Have a history of chest radiation before age 30
Present with palpable lumps, nipple changes, or focal pain
Have dense breast tissue or implants where traditional mammography may be limited
Experience pain, intolerance, or delayed imaging due to compression
3D Breast CT is a diagnostic alternative, not a replacement for traditional mammography, and is most useful in clearly defined clinical scenarios.
Prior mammography had abnormal or inconclusive findings and need further evaluation
Carry BRCA1/BRCA2 gene mutations or other genetic syndromes
Have a history of chest radiation before age 30
Present with palpable lumps, nipple changes, or focal pain
Have dense breast tissue or implants where traditional mammography may be limited
Experience pain, intolerance, or delayed imaging due to compression
Traditional mammography compresses the breast into limited 2D views, where overlapping structures can obscure small lesions, particularly in dense tissue. Dedicated Breast CT acquires a full 3D volume of the breast in a single 10-second scan, reducing tissue overlap and enabling clearer visualization of anatomy and pathology. Published performance specifications indicate our system can visualize tumors as small as 2mm and calcifications down to 200 microns, including findings that can be obscured on conventional 2D mammography.
Breast cancer risk is common, yet many women are not receiving routine breast imaging.
In the U.S., about 85 million women are eligible for annual mammography, yet only ~33 million exams are performed each year. This utilization gap translates into missed opportunities for early detection.
Survey data show that nearly half of women age 40+ who are eligible for annual mammograms do not complete them each year, and more than 1 in 10 have never had one. Many women also delay or avoid exams because of pain, anxiety, or prior negative experiences with compression.
For clinicians, this does not just mean “lost baselines.” It means more cancers found at later, harder-to-treat stages and fewer patients diagnosed when disease is most curable.
Gnosis for Her is designed to reduce these barriers and help appropriate patients re-enter a consistent breast imaging pathway through a comfortable, diagnostic option.
Breast cancer risk is common, yet many women are not receiving routine breast imaging.
In the U.S., about 85 million women are eligible for annual mammography, yet only ~33 million exams are performed each year. This utilization gap translates into missed opportunities for early detection.
Survey data show that nearly half of women age 40+ who are eligible for annual mammograms do not complete them each year, and more than 1 in 10 have never had one. Many women also delay or avoid exams because of pain, anxiety, or prior negative experiences with compression.
For clinicians, this does not just mean “lost baselines.” It means more cancers found at later, harder-to-treat stages and fewer patients diagnosed when disease is most curable.
Gnosis for Her is designed to reduce these barriers and help appropriate patients re-enter a consistent breast imaging pathway through a comfortable, diagnostic option.
Our Clinical Safety
Comparable radiation dose to traditional mammography • FDA-cleared for diagnosis • Quality assurance aligned with national standards
Dedicated Breast CT delivers radiation exposure within the same range as standard mammography, including in patients with dense breast tissue. The dose profile is aligned with ALARA principles and accepted national imaging standards, making it an appropriate diagnostic option when additional anatomical clarity is needed.
The Koning Vera Breast CT system used by Gnosis for Her is FDA-cleared for diagnostic breast imaging after rigorous review of safety, performance, and effectiveness data. The device meets federal performance requirements and is subject to ongoing quality assurance and regulatory oversight.
For clinicians, this means you can consider Breast CT without increasing radiation risk while gaining a true 3D view that may reduce repeat imaging, callbacks, and diagnostic uncertainty.
Our Clinical Safety
Comparable radiation dose to traditional mammography • FDA-cleared for diagnosis • Quality assurance aligned with national standards
Dedicated Breast CT delivers radiation exposure within the same range as standard mammography, including in patients with dense breast tissue. The dose profile is aligned with ALARA principles and accepted national imaging standards, making it an appropriate diagnostic option when additional anatomical clarity is needed.
The Koning Vera Breast CT system used by Gnosis for Her is FDA-cleared for diagnostic breast imaging after rigorous review of safety, performance, and effectiveness data. The device meets federal performance requirements and is subject to ongoing quality assurance and regulatory oversight.
For clinicians, this means you can consider Breast CT without increasing radiation risk while gaining a true 3D view that may reduce repeat imaging, callbacks, and diagnostic uncertainty.
Breast CT remains well within accepted breast imaging ranges.
Board-certified radiologist with dedicated breast imaging expertise
Standardized BI-RADS structured reporting returned to your practice
Ongoing guality assurance aligned with national breast imaging standards
Images generated are DICOM compliant and directly plug into most RIS/PACS systems for remote viewing
Clear communication for urgent or suspicious findings
Gnosis for Her partners with radiologists who have decades of experience in women’s imaging, following well-established clinical protocols for breast imaging interpretation.
Gnosis for Her operates as a CDPH-regulated mammography facility. Our Dedicated Breast CT (DBCT) system is state-certified under the California Department of Public Health Radiologic Health Branch, meeting the same safety, quality, and physicist oversight standards required of traditional mammography equipment. Read more at this link.
Board-certified radiologist with dedicated breast imaging expertise
Standardized BI-RADS structured reporting returned to your practice
Ongoing guality assurance aligned with national breast imaging standards
Images generated are DICOM compliant and directly plug into most RIS/PACS systems for remote viewing
Clear communication for urgent or suspicious findings
Gnosis for Her partners with radiologists who have decades of experience in women’s imaging, following well-established clinical protocols for breast imaging interpretation.
Gnosis for Her operates as a CDPH-regulated mammography facility. Our Dedicated Breast CT (DBCT) system is state-certified under the California Department of Public Health Radiologic Health Branch, meeting the same safety, quality, and physicist oversight standards required of traditional mammography equipment. Read more at this link.
The patient will select a convenient time and location in Southern California here. After scheduling, they will request a referral from their medical provider using our requisition form.
Diagnostic imaging scans in California require an order from a licensed medical provider.
If you have completed a signed requisition for your patient, they may submit it directly during our online patient registration. If not, you can download our requisition form here and send to us.
Completed requisitions may be faxed to 714.279.2020 or emailed to [email protected].
Once the patient arrives at our mobile care unit, they are checked in and welcomed by our radiologic technologist. For the Breast CT scan, the patient lies comfortably face down on the device inside our private mobile unit while the scanner rotates 360° around each breast, capturing images without compression or contact. Each breast is scanned in ~10 seconds, and the entire visit typically takes 15–20 minutes in a calm, low-stress environment designed to reduce barriers to imaging.
The scan is interpreted by a board-certified radiologist and the structured report is securely delivered to your practice. Results are typically available within 72 hours when prior imaging is promptly provided, or up to 14 days when prior imaging is not available. The patient receives their results directly through their patient portal, and your office receives the full radiology report for follow-up and care coordination.
gnosis /no-sis/ n. from the Greek term meaning “knowledge through experience,” “known” or “to know.” Gnosis for Her puts women at the forefront of women’s health. From the moment you schedule your appointment to your first steps inside our comforting and thoughtfully designed mobile care unit — it’s all with patients in mind.
gnosis /no-sis/ n. from the Greek term meaning “knowledge through experience,” “known” or “to know.” Gnosis for Her puts women at the forefront of women’s health. From the moment you schedule your appointment to your first steps inside our comforting and thoughtfully designed mobile care unit — it’s all with patients in mind.
Koning Vera produces high-contrast, true 3D images with exceptional spatial resolution. This improves how clinicians evaluate breast tissue, while giving patients a more comfortable experience—no compression required, faster scans, and fewer patient recalls. It also saves time and streamlines workflow.
It’s a dedicated breast CT system that creates isotropic 3D images of the breast. It can be used for diagnostic imaging and 3D-guided biopsies, with or without contrast dye. The system is built in the USA.
Yes. Radiation exposure is comparable to a standard 2D mammogram and fully adheres to Mammography Quality Standards Act (MQSA) limits. For biopsies, Koning Vera uses about 50% less radiation than traditional stereotactic methods. An average person’s annual background radiation exposure is ~3.1 mSv, whereas the Gnosis for Her 3D Breast CT is ~0.7 mSv (Non-Contrast). That’s about 75% less radiation than what you’re naturally exposed to in a year.
Yes. The Koning Vera has received FDA Premarket Approval (PMA) for both breast CT and 3D guided biopsy—this is the highest level of FDA clearance for medical devices.
Gnosis for Her currently offers the service as self-pay, with FSA/HSA reimbursement eligible. However, we are working toward broader insurance coverage. As of January 2021, the American Medical Association assigned six dedicated CPT codes for Breast CT, now being accepted by many payers.
Gnosis for Her is available in California through our mobile breast imaging unit. Patients can schedule appointments at the community locations where our mobile clinic is stationed each week.
We are planning to expand with additional mobile units and locations in the future, making this technology more widely accessible.
Not yet. Currently, Koning Vera is used for diagnostic imaging after a screening mammogram. However, a clinical trial is underway for screening use, with approval anticipated in 2026.
Visit the Koning Health website
View the Koning Health brochure
Read the FDA Safety and Effectiveness Data
Read the California Dept of Public Health Announcement for DBCT
Read the Koning Health Citations
Read the European Radiology clinical study on Cone-Beam Breast CT
Read the European Journal of Radiology article on 3D Breast CT diagnostic performance
Read the PubMed study on Cone-Beam Breast CT for detecting microcalcifications
Read the PubMed study on early clinical evaluation of dedicated Breast CT
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Have Questions?
Email us at: [email protected]
Call us at 888.311.5220
Sign up for Gnosis for Her updates to stay in the know.
Have Questions?
Email us at: [email protected]
Call us at 888.311.5220
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