Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1418960

FEI Number

1418960

Entity Name

MINXRAY, INC.

City/State/Country

NORTHBROOK, IL, US

Establishment Address

3611 COMMERCIAL AVE., NORTHBROOK, IL 60062, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

The Kretchmer Corp. (Owner Number: 9006653)

Owner / Operator Contact Address

3611 Commercial Ave., --, Northbrook, IL 60062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210479

PMA Number

N/A

All Registered Proprietary Names

MinXray CMDR.CW.1202.S MinXray CMDR.CW.120.60.R MinXray CMDR.CW.100.R MinXray CMDR.CW.120.60S MinXray CMDR.CW.1202.R MinXray CMDR.CW.100.S MinXray CMDR.T.120.60.S MinXray CMDR-2SLWT MinXray CMDR.T.120.60.R MinXray CMDR.PE.1202.R MinXray CMDR.PE.100.R MinXray CMDR.TW.120.60.S MinXray CMDR.PE.1202.S MinXray Integris MinXray CMDR.T.100.S MinXray CMDR.TW.100.R MinXray CMDR.T.1202.R MinXray CMDR.TW.1202.R MinXray CMDR.T.100.R MinXray CMDR.PE.100.S MinXray CMDR.T.1202.S MinXray CMDR.TW.120.60.R MinXray CMDR.PE.120.60.S MinXray CMDR.PE.120.60.R MinXray CMDR.TW.100.S MinXray CMDR.TW.1202.S CMDR.C.120.60.S CMDR.C.100.R CMDR.C.1202.R CMDR.C.1202.S CMDR.C.100.S CMDR.C.120.60.R MinXray IMPACT & X-Ranger

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-07-03
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2019-07-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-07-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-18
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-08-18
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2016-08-18
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2017-06-22
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-06-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-06-22
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-07-13
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2020-07-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-07-13
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-10-05
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2021-10-05

Official Correspondent

Mark Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Kretchmer Corp.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Similar Registrations

Registration Number	Establishment Name	Location
3016256852	KA IMAGING INC.	Waterloo Ontario, CA
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3038614464	Canon.Inc	OHTA-KU Tokyo, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1418960. Last updated year: 2026. Please use registration number 1418960 when referencing this establishment in official correspondence.