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.
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.
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 |
|---|---|---|
| CPT Procedure Codes | ||
| 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 |
| ICD-10 Diagnosis Codes | ||
| 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.
| Electrical | Standard single phase, 240V, 35 Amp |
| Table Capacity | 200 kg (~441 lbs.) |
| Table Height (Biopsy) | Elevates to 1.5 m (~5 ft.) |
| Recommended Room | 3 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 PDFRadiation Dose Comparison
Detailed radiation dose data showing Vera Breast CT delivers imaging at a comparable dose to standard diagnostic mammography.
Download PDFPhysician Fact Sheet
Physician Fact SheetClinical overview of system capabilities, indications, CPT codes, and how Vera CT supports your diagnostic workup.
Download PDFPatient Education Brochure
Plain-language materials explaining the Vera Scan experience, benefits, and what patients can expect during their visit. Ready to share.
Download PDFRefer a Patient for Breast CT
Complete the form below to initiate a referral. A requisition from the referring physician is required before scheduling.
Your Information
Patient & Referral Details
Referral Received
Thank you, . Our team will follow up within one business day to confirm the referral and coordinate with your patient.
Questions? Call us at 832-263-8423.
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.
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.
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.
