Data / Medical devices / Generator, High-Voltage, X-Ray, Diagnostic

Generator, High-Voltage, X-Ray, Diagnostic (IZO): 35 FDA-registered makers in 13 countries

Name: FDA-registered makers of Generator, High-Voltage, X-Ray, Diagnostic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

35 establishments in 13 countries are registered with the FDA to make Generator, High-Voltage, X-Ray, Diagnostic (product code IZO, Class 1, 21 CFR 892.1700). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 163 510(k) clearances under this code, the latest on November 24, 1995, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: IZO
Device class: 1
Regulation: 892.1700
Medical specialty: Radiology

Makers by country

Country	Makers
China	7
United States	5
South Korea	5
Germany	4
Mexico	3
Canada	2
India	2
Japan	2
France	1
Italy	1
Spain	1
Netherlands	1
Philippines	1

Makers of Generator, High-Voltage, X-Ray, Diagnostic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Philips Medical Systems DMC GmbH	Hamburg, Germany	Complaint file establishment, Manufacturer	1	October 7, 1993	api.fda.gov
Carestream Health, Inc., Global R&D Center	Shanghai, China	Specification developer	0		api.fda.gov
Communications & Power Industries Canada, Inc.	GEORGETOWN Ontario, Canada	Manufacturer	0		api.fda.gov
Compania Mexicana De Radiologia CGR, S.A. De C.V.	Queretaro, Mexico	Manufacturer	0		api.fda.gov
Carestream Healthcare International Company, Ltd	Shanghai, China	Manufacturer	0		api.fda.gov
Del Medical, Inc.	Bloomingdale, IL, United States	Manufacturer	0		api.fda.gov
Drgem Corporation	Gwangmyeong-si Gyeongbuk, South Korea	Complaint file establishment, Specification developer	0		api.fda.gov
DRGEM Corporation (Gimcheon Factory)	Gimcheon-si Gyeongbuk, South Korea	Manufacturer	0		api.fda.gov
DRTECH Corporation	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
ECOTRON Co., Ltd.	Seoul, South Korea	Manufacturer	0		api.fda.gov
Emd Technologies Incorporated	SAINT-EUSTACHE Quebec, Canada	Manufacturer	0		api.fda.gov
Ge Be Private Limited	WHITEFIELD, BANGALORE Karnataka, India	Manufacturer, Specification developer	0		api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.	APODACA Nuevo Leon, Mexico	Manufacturer	0		api.fda.gov
Ge Medical Systems SCS	Buc, France	Manufacturer, Specification developer	0		api.fda.gov
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC	Madison, WI, United States	Specification developer	0		api.fda.gov
Gilardoni S.P.A.	MANDELLO DEL LARIO Lecco, Italy	Manufacturer	0		api.fda.gov
Hefei MT Medical Co.,ltd.	Hefei Anhui, China	Exporter to the US, Manufacturer	0		api.fda.gov
Sedecal S.A.	ALGETE Madrid(Province), Spain	Manufacturer	0		api.fda.gov
Shimadzu Corporation Medical Systems Division	Kyoto, Japan	Contract manufacturer, Manufacturer	0		api.fda.gov
Shimane Shimadzu Corporation	IZUMO Shimane, Japan	Contract manufacturer, Manufacturer	0		api.fda.gov
Shinyoung For M Co., Ltd.	Namyangju-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
Siemens X-Ray Vacuum Technology Ltd.	Wuxi Jiangsu, China	Contract manufacturer	0		api.fda.gov
Spellman GMBH	Bochum North Rhine-Westphalia, Germany	Manufacturer	0		api.fda.gov
Spellman High Voltage Electronics Corp.	Hauppauge, NY, United States	Manufacturer	0		api.fda.gov
Spellman High Voltage Electronics(suzhou Industrial Park)co.,ltd	Suzhou Jiangsu, China	Manufacturer	0		api.fda.gov
Summit Industries, LLC	Niles, IL, United States	Manufacturer	0		api.fda.gov
Suzhou Powersite Electric Co., Ltd.	Suzhou Jiangsu, China	Manufacturer	0		api.fda.gov
Siemens Healthineers AG	FORCHHEIM Bavaria, Germany	Manufacturer	0		api.fda.gov
Siemens Healthineers AG	ERLANGEN Bavaria, Germany	Manufacturer	0		api.fda.gov
Spellman de Mexico Plant 3	Matamoros Tamaulipas, Mexico	Manufacturer	0		api.fda.gov
Varex Imaging Corporation	Franklin Park, IL, United States	Contract manufacturer	0		api.fda.gov
Varex Imaging Nederland B.V.	Doetinchem Gelderland, Netherlands	Complaint file establishment, Manufacturer	0		api.fda.gov
Varex Imaging Philippines Inc.	Batino, Calamba City Laguna, Philippines	Contract manufacturer	0		api.fda.gov
Wipro Ge Healthcare Private Ltd	WHITEFIELD, BANGALORE Karnataka, India	Manufacturer	0		api.fda.gov
iRay Imaging Technology (Haining) Limited	Haining Zhejiang, China	Complaint file establishment, Manufacturer, Specification developer	0		api.fda.gov

Updated November 24, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.