Koning Breast CT (Model CBCT1000)
by Koning Corporation PMA
Active
PMA P130025
Overview
The Koning Breast CT (Model CBCT1000) is a Cone Beam Computed Tomography (CBCT) system classified as a cross-sectional mammographic X-ray device. It generates three-dimensional images of the breast for diagnostic purposes, complementing standard 2-view mammography (craniocaudal and mediolateral oblique views).
This device is intended for use in radiology settings and is supplied as a Class III medical device under FDA Premarket Approval (PMA P130025). The Koning Breast CT is not described as single-use or reusable in the specifications, and no MRI safety information is provided. Storage and handling instructions are not detailed beyond its intended use in diagnostic imaging.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP130025 | Date14 Jan 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Koning Breast CT, KBCT
- Trade Name
- Koning Breast CT (Model CBCT1000)
- Generic Name
- Cross-sectional mammographic xray system
- PMA Number
- FDA Product Code
- OLQ
- Device Class
- Class III
- Advisory Committee
- Radiology
- FDA Decision
- APPR Approved
Other devices from Koning Corporation
Questions
What is the primary clinical purpose of the Koning Breast CT (Model CBCT1000) in diagnostic imaging?
The Koning Breast CT (Model CBCT1000) is designed to generate **three-dimensional images** of the breast, serving as a complementary tool to standard **2-view mammography** (craniocaudal and mediolateral oblique views). It provides cross-sectional imaging to enhance diagnostic evaluation beyond traditional 2D mammography.
How is the Koning Breast CT (Model CBCT1000) classified and regulated in the U.S.?
The Koning Breast CT is classified as a **Class III medical device** under the FDA’s Premarket Approval (PMA) pathway, with approval granted under **PMA P130025**. This classification reflects its role as a **Cone Beam Computed Tomography (CBCT) system** for breast imaging, requiring rigorous review before market authorization.
Is the Koning Breast CT (Model CBCT1000) intended for single-use or reusable applications?
The provided data does not specify whether the Koning Breast CT is designed for **single-use or reuse**. Since it is a **fixed imaging system** (not a disposable component), it is likely intended for **repeated use** in radiology settings, though operational details like maintenance or sterilization protocols would require consultation with Koning Corporation.
What types of imaging views does the Koning Breast CT complement, and how does it differ from standard mammography?
The Koning Breast CT is **not a replacement** for standard mammography but complements it by providing **3D volumetric imaging** alongside the traditional **2-view mammography** (craniocaudal and mediolateral oblique). While mammography captures flat, 2D projections, the CBCT system offers cross-sectional slices for more detailed spatial assessment of breast tissue.
Are there any specific storage or handling requirements mentioned for the Koning Breast CT?
The documentation does not provide detailed **storage or handling instructions** beyond its **diagnostic imaging purpose** in radiology settings. Since it is a **fixed imaging system**, proper environmental conditions (e.g., temperature, humidity) and maintenance protocols would be critical, but these would need to be confirmed directly with Koning Corporation for operational compliance.