Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1418964

FEI Number

1418964

Entity Name

DEL MEDICAL, INC.

City/State/Country

Bloomingdale, IL, US

Establishment Address

241 Covington Dr, Bloomingdale, IL 60108, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Del Medical, Inc (Owner Number: 10031137)

Owner / Operator Contact Address

241 Covington Drive, Bloomingdale, IL 60108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173018

PMA Number

N/A

All Registered Proprietary Names

Hydra Vision AL02 R225 FWFC (non-rotate) FMT OTC18M OTC18T OTC18S FMT18M FWFC (rotate) FMT18T FM-FMT18T FM-FMT18M DM-FMT18T FM-OTC18M DM-OTC18M DMX DM-FWFC CM-OTC18M DM-FMT18M FM-OTC18T DM-OTC18S DM-OTC18T DM-FMT CM-OTC18T DelWorks MT500-EL EV800 EV800T MT500-EB RT100 ML03 R221 RB100 Hydra Vision VT300 (5187) VT300 (5150) UARM VS300 VT300T VS100 VS50 VT300 (5157) SARM MT500-F MT500 KA Reveal Mobi Pro MDR

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	2024-07-25
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2026-03-30
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2013-11-14
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2009-12-23
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-04-26
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2015-12-07
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2009-12-23
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2018-10-10
IXJ	Grid, Radiographic	Radiology	Class 1	892.1910	2015-05-06
KQS	Table, Cystometric, Non-Electric And Accessories	Gastroenterology, Urology	Class 1	876.4890	2024-07-26
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	2009-12-23
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2017-01-31
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-06-11

Official Correspondent

George Bell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Del Medical, Inc

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
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21

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-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.

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 1418964. Last updated year: 2026. Please use registration number 1418964 when referencing this establishment in official correspondence.