Koning Breast CT System

Primary DI
00850065527000
Brand
Koning Breast CT System
Company
KONING CORPORATION
Model
CBCT 1000
Catalog number
CBCT 1000
Device description
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.
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLQCross-Sectional Mammographic Xray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLQCross-Sectional Mammographic Xray SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130025004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130025004KONING BREAST CT (MODEL CBCT1000)Koning Corporation2015-01-14OLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065527000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065527000008500655270008500655270000850065527000

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, mammographicA 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 hung breast may be scanned.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145060716
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19764496368300Koning Breast CT SystemCBCT 1000CBCT 10002025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
19764496368300Koning Breast CT SystemKONING CORPORATIONOLQ2025-07-17