FDA.reportPublic FDA data

KONING CORPORATION

Matched from indexed company URL: Koning Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085130543008513054KONING CORPORATION1N2026-01-015555 Oakbrook Pkwy Ste 640 Norcross GA US 30093

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
19764496368300Koning Breast CT System - 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 breastusing 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 anx-ray source assembly and flat panel X-ray detector (gantry), high-frequency generator, and operating console with reconstruction software; it typically includesa patient table/platform with a hole through which the breast is inserted and scanned.678-481-9246ty.cowart@koningcorporation.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1191021965271489P130025KONING BREAST CT (MODEL CBCT1000)OLQ2015-01-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLQ 22015-01-14

PMA#

GUDID#

Koning Breast CT System - 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

2026-03-04

Koning Breast CT System - 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 breastusing 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 anx-ray source assembly and flat panel X-ray detector (gantry), high-frequency generator, and operating console with reconstruction software; it typically includesa patient table/platform with a hole through which the breast is inserted and scanned.

KONING CORPORATION

2025-07-17