Koning Breast CT System CBCT 1000

GUDID 00850065527000

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: 00850065527000
• NIH Device Record Key: 2b3e5dd1-dc84-4b17-aec6-3bbf8d25d548
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065527000 [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: 2026-03-12
• Device Publish Date: 2026-03-04

On-Brand Devices [Koning Breast CT System]

• 19764496368300: A stationary assembly of mains electricity (AC-powered) devices intended to produce two or three
• 00850065527000: A stationary assembly of mains electricity (AC-powered) devices intended to produce two or three