Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1450503

FEI Number

1450503

Entity Name

SUMMIT INDUSTRIES, LLC

City/State/Country

Niles, IL, US

Establishment Address

7555 N. Caldwell Avenue, Niles, IL 60714, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

SUMMIT INDUSTRIES, LLC (Owner Number: 1450503)

Owner / Operator Contact Address

7555 N. Caldwell Avenue, --, Niles, IL 60714, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

L550 L300 L500 03900 00210 03901 FMT System DFMT System S105 S203 S225 S113 J700 J309 S114 A-172F S108 S109 S111 J1000 S107 S102 DFMT System LX125 D800 C256 S204 S212 S200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2001-07-18
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-05-31
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2022-05-31
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2001-11-26
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	2001-11-26
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2022-05-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-05-31
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2008-02-01
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2001-11-26

Official Correspondent

Joe Flies

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SUMMIT INDUSTRIES, LLC

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
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23
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

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
1483291	Varex Imaging Corporation	Franklin Park, IL, US
3007603422	Althea US, Inc.	Goodlettsville, TN, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
3005172103	DRTECH Corporation	Seongnam-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450503. Last updated year: 2026. Please use registration number 1450503 when referencing this establishment in official correspondence.