Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1418484

FEI Number

1418484

Entity Name

X-CEL X-RAY CORP.

City/State/Country

Crystal Lake, IL, US

Establishment Address

4220 WALLER ST, --, Crystal Lake, IL 60012, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARQUILLA, INC DBA X-CEL X-RAY CORP. (Owner Number: 1418484)

Owner / Operator Contact Address

4220 WALLER ST, --, Crystal Lake, IL 60012, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K871116

PMA Number

N/A

All Registered Proprietary Names

X-Cel X-Ray Corporation X-Cel X-Ray Corporation X-Cel X-Ray Corporation X-Cel X-Ray Corporation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2021-01-29
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1992-07-20
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2017-07-19
IYH	Generator, Dermatological (Grenz Ray), Therapeutic X-Ray	Radiology	Class 2	892.5900	2021-01-29

Official Correspondent

GUIDO ARQUILLA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARQUILLA, INC DBA X-CEL X-RAY 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
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21
K123106	Samsung Electronics Co., Ltd.	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20
K203340	Siemens Medical Solutions USA, Inc.	MULTIX Impact C	2021-01-06
K230241	Sg Healthcare Co, Ltd.	Jumong General	2023-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015	Siemens Medical Solutions USA, Inc	2	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1418484. Last updated year: 2026. Please use registration number 1418484 when referencing this establishment in official correspondence.