Koning Breast CT System CBCT 1000

GUDID 19764496368300

A stationary assembly of mains electricity (AC-powered) devices intended to produce two or three-dimensional (3-D) diagnostic digital x-ray images of a patient’s breast using cone beam computed tomography (CBCT); it may be intended to assist a breast biopsy procedure by providing 3-D localization and guidance. It consists of an x-ray source assembly and flat panel X-ray detector (gantry), high-frequency generator, and operating console with reconstruction software; it typically includes a patient table/platform with a hole through which the breast is inserted and scanned.

KONING CORPORATION

Cone beam computed tomography system, mammographic

• Primary Device ID: 19764496368300
• NIH Device Record Key: 0d06219c-b9d9-4470-9fde-8e5b98c49e1f
• Commercial Distribution Discontinuation: 2035-07-16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koning Breast CT System
• Version Model Number: CBCT 1000
• Catalog Number: CBCT 1000
• Company DUNS: 145060716
• Company Name: KONING CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com
• Phone: 678-481-9246
• Email: ty.cowart@koningcorporation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	19764496368300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130025

FDA Product Code

• OLQ: Cross-Sectional Mammographic Xray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-25
• Device Publish Date: 2025-07-17