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For Referring Physicians

FDA-Approved Diagnostic Breast CT

The Artemis Breast CT, utilizing Koning Vera Technology, is one of the first CT devices to receive FDA PMA approval for commercial diagnostic use and 3D-guided biopsy. Review clinical specs, indications, and CPT codes below — or refer a patient directly.


FDA PMA
P130025 · Highest bar of FDA approval
6 CPT Codes
AMA-listed · 0633T–0638T · Effective 1/2021
RadSite
CMS-recognized accreditation for CBCT imaging
1 in 6
women are deterred from yearly mammograms
due to pain and discomfort from compression
Siemens Health study
35%
of breast cancers are missed
in initial breast imaging exams
1 in 8
women are diagnosed with breast cancer
every year
American Cancer Society

Why Refer Patients to Artemis for Breast CT?

Koning Vera Breast CT (KBCT) is a 3D diagnostic breast imaging device that produces high-contrast, real isotropic 3D images without painful compression — at radiation levels similar to a diagnostic mammogram. Each voxel is equal in all three dimensions, giving your radiologist a complete volumetric dataset rather than a stack of 2D projections.

KBCT introduces MPR (Multi-Planar Reconstruction) to breast imaging, delivering simultaneous co-registration in multiple planes — eliminating the need to extrapolate image data from 2D compressional mammography. Its 360° acquisition provides excellent tissue coverage from nipple to chest wall regardless of breast size, and is a more effective method of imaging the augmented breast without requiring double the exposure dose.

For patients who require biopsy, Vera Breast CT can be configured with 3D-guided biopsy — a rapid-mount accessory that replaces stereotactic biopsy equipment and reduces patient radiation by over 50%.

Benefits of KBCT

  • No Compression, No Pain — breast presented in natural form, no deformation
  • Full 3D image — all information with one scan, no extra views needed
  • No tissue overlap — better detection in dense tissue; true isotropic voxels, no preferred plane
  • Images all breast types — small, large, implants; no double dose for augmented breasts
  • Safe, low dose — radiation in range of diagnostic mammograms (~5.8 mGy bilateral)
  • Non-gadolinium contrast — non-ionic CT agent, images calcifications, no gadolinium retention risk
  • Sensitivity 85.6–89.2% (non-contrast), up to 98.7% (contrast-enhanced)
  • Compatible with pacemakers, metal implants, and augmented breasts

Radiation Dose & Clinical Performance

Vera Breast CT delivers a superior diagnostic image at a radiation dose comparable to a diagnostic mammogram — with notably higher sensitivity, especially with contrast enhancement. Source: Koning Breast CT Regulatory Clinical Trials and published literature.

Modality Diagnostic Dose
(small/avg breast)
Sensitivity Specificity Compression
Vera Breast CT
No contrast
5.8 mGy 85.6–89.2% 79.5–84.0% None
Vera Breast CT
With contrast
11.6 mGy 92.7–98.7% 79.5–85.0% None
FFDM (Diagnostic workup) 9.5–13.8 mGy 76.1–84.5% 73.1–81.3% Required
DBT (Diagnostic workup) 13.8–18.2 mGy 77.2–88.0% 71.0–84.8% Required

Source: Koning Breast CT Regulatory Clinical Trials; He, N. et al., Eur J Radiol 2016; Gilbert, F.J. et al., Radiology 2015. Doses reflect diagnostic workup scenario for small/average breasts.

Artemis Breast CT Can Replace

Consolidate multiple imaging and procedure modalities into one platform.

Replaces
Diagnostic Mammograms
With no compression — no pain, no deformation, breast presented in its natural form for superior image quality, especially in small dense breasts.
Replaces
Stereotactic Biopsy Devices
3D-guided biopsy accessory improves accuracy and reduces patient radiation by over 50% compared to stereotactic biopsy — completed in approximately 30 minutes.
Replaces
MRI Exams
No gadolinium, no claustrophobia — and unlike MRI, Vera Breast CT images calcifications. Ideal for patients with gadolinium sensitivity or implanted devices.

When to Order Breast CT

Koning Vera Breast CT is indicated for diagnostic imaging in patients who require additional evaluation. CPT codes 0633T–0638T are AMA-listed and effective January 2021.

Code Procedure / Description Indications / Clinical Context
0633T Unilateral without contrast Callback from mammogram, palpable mass, post-surgical follow-up, implant rupture question
0634T Unilateral with contrast Personal/family history with callback, indeterminate findings, nipple discharge
0635T Unilateral with/without contrast Indeterminate findings, symptoms, biopsy-proven carcinoma follow-up, extent of disease
0636T Bilateral without contrast Bilateral symptoms, bilateral callbacks, implant integrity check, pre/post-procedural
0637T Bilateral with contrast Biopsy-proven carcinoma extent, contralateral involvement, high-risk patient
0638T Bilateral with/without contrast Bilateral symptoms with family history, neo-adjuvant monitoring, post-surgical changes
R92.2 Inconclusive mammogram due to dense breasts Dense breast tissue limiting mammography sensitivity; primary indication for supplemental CT imaging
R92.0 Mammographic microcalcification found on diagnostic imaging Further evaluation of calcification morphology, distribution, and extent
R92.8 Other abnormal and inconclusive findings on diagnostic imaging Architectural distortion, asymmetry, or other inconclusive mammogram findings
N64.59 Other signs and symptoms in breast Palpable mass, nipple discharge, skin changes, or unexplained breast pain
Z85.3 Personal history of malignant neoplasm of breast Post-treatment surveillance in breast cancer survivors
Z80.3 Family history of malignant neoplasm of breast Elevated risk due to first-degree relative with breast cancer
Z15.01 Genetic susceptibility to malignant neoplasm of breast BRCA1/BRCA2 positive or other hereditary risk mutation carrier
Z98.82 Breast implant status Implant integrity evaluation when mammography is limited or inconclusive

Complete Referral Indications

Order Breast CT when your clinical exam or previous imaging suggests any of the following. A physician requisition is required to schedule.

Mammographic Findings

  • Breast density causing indeterminate mammograms
  • Abnormal findings — asymmetries or scars from previous exams
  • Patient called back for additional imaging
  • Micro or pleomorphic calcifications on previous images
  • History of breast cancer
  • Family history of breast or ovarian cancer
  • Biopsy-proven benign mass / fibroadenoma

Signs & Symptoms

  • Pain
  • Lump
  • Swelling
  • Thickening
  • Nipple discharge or changes
  • Abscess
  • Implant rupture or risk of rupture
  • Implant removal or planning

MRI Contraindications

When Breast MRI is recommended but not possible, Breast CT can provide comparable diagnostic value for patients who:

  • Exceed weight or size limitations on MRI
  • Have claustrophobia
  • Have compromised renal function
  • Have a metal implantable device
  • Have concerns about gadolinium retention in the brain
  • Have had indeterminate MRI results due to background parenchymal enhancement

Artemis Imaging System — Partial Specifications

Key installation and performance specs for the Koning Vera Breast CT system.

ElectricalStandard single phase, 240V, 35 Amp
Table Capacity200 kg (~441 lbs.)
Table Height (Biopsy)Elevates to 1.5 m (~5 ft.)
Recommended Room3 m × 4.3 m (~10 ft. × ~14 ft.)
Resolution (Hi-Res mode)0.155 mm
Voxel Size (Standard)0.200 mm

System Capabilities at a Glance

  • Real isotropic 3D imaging — true volumetric dataset in every dimension
  • MPR: simultaneous co-registration in multiple planes
  • 360° acquisition from nipple to chest wall, all breast sizes
  • Optional 3D-guided biopsy mount — >50% dose reduction vs. stereotactic
  • Optional contrast-enhanced breast CT configuration
  • Hallway clearance: minimum 1.6 m; gantry 1900 kg over 1.2 m × 2.3 m

Physician Resources

Clinical and technical materials from Artemis Imaging — ready for your reference or to share with your team.

Tech Specs Comparison Brochure

Side-by-side technical comparison of Vera Breast CT versus conventional mammography — resolution, geometry, and diagnostic capability.

Download PDF

Radiation Dose Comparison

Detailed radiation dose data showing Vera Breast CT delivers imaging at a comparable dose to standard diagnostic mammography.

Download PDF

Physician Fact Sheet

Physician Fact SheetClinical overview of system capabilities, indications, CPT codes, and how Vera CT supports your diagnostic workup.

Download PDF

Patient Education Brochure

Plain-language materials explaining the Vera Scan experience, benefits, and what patients can expect during their visit. Ready to share.

Download PDF

Refer a Patient for Breast CT

Complete the form below to initiate a referral. A requisition from the referring physician is required before scheduling.

Case Study 1

57-Year-Old, Dense Breast Tissue

A contrast-enhanced Breast CT scan identified multi-focal malignant masses in two separate quadrants — findings a mammogram had read as negative.

Case Study 2

60-Year-Old, Ductal Carcinoma in Situ

Breast CT displayed the true 3D distribution of the calcification clusters tied to the diagnosis — detail not resolvable on standard mammography.

Case Study 3

61-Year-Old, Small Breast, Grade 3 Invasive Ductal Carcinoma

Mammography had limited coverage of the chest wall and posterior tissue. Breast CT fully visualized the lesion and the surrounding posterior tissue.

Case data from Koning Corporation clinical case study materials.

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