Data / Medical devices / Assembly, Tube Housing, X-Ray, Diagnostic

Assembly, Tube Housing, X-Ray, Diagnostic (ITY): 38 FDA-registered makers in 9 countries

Name: FDA-registered makers of Assembly, Tube Housing, X-Ray, Diagnostic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

38 establishments in 9 countries are registered with the FDA to make Assembly, Tube Housing, X-Ray, Diagnostic (product code ITY, Class 1, 21 CFR 892.1760). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on February 10, 2000, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: ITY
Device class: 1
Regulation: 892.1760
Medical specialty: Radiology

Makers by country

Country	Makers
China	13
United States	10
Germany	4
Japan	2
India	2
Mexico	2
Italy	2
South Korea	2
France	1

Makers of Assembly, Tube Housing, 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	Recall events	Source
Amirix Imaging	Newbury Park, CA, United States	Manufacturer	0	api.fda.gov
Beijing Smartbeam Medical Devices Co., LTD	Beijing, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Canon Electron Tubes & Devices Co., Ltd.	Otawara-shi Tochigi, Japan	Manufacturer	0	api.fda.gov
Chronos Imaging, LLC	Aurora, IL, United States	Contract manufacturer, Manufacturer	1	api.fda.gov
Ge Be Private Limited	WHITEFIELD, BANGALORE Karnataka, India	Manufacturer, Specification developer	0	api.fda.gov
Ge Hangwei Medical Systems Co., Ltd.	Beijing, China	Manufacturer	0	api.fda.gov
GE Healthcare (China) Co., Ltd.	Beijing, China	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, LLC	Milwaukee, WI, United States	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
Hangzhou Kailong Medical Instruments Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	0	api.fda.gov
Iae SPA	Cormano Milano, Italy	Manufacturer	0	api.fda.gov
Konason (guangdong) Medical Imaging Technology Co., Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Lucem Co., Ltd.	Gumi-si Gyeongbuk, South Korea	Manufacturer	0	api.fda.gov
Mingwei Medical Technology(suzhou) Co.,ltd	Suzhou Jiangsu, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Micro X-ray Technology (Suzhou) Co., Ltd	suzhou Jiangsu, China	Manufacturer	0	api.fda.gov
Philips Medical Systems DMC GmbH	Hamburg, Germany	Complaint file establishment, Exporter to the US, Manufacturer, Specification developer	0	api.fda.gov
Richardson Electronics	Lafox, IL, United States	Complaint file establishment, Manufacturer, Remanufacturer	0	api.fda.gov
Shimadzu Corporation Medical Systems Division	Kyoto, 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, 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
Siemens Healthineers AG	FORCHHEIM Bavaria, Germany	Manufacturer, Specification developer	0	api.fda.gov
Siemens Healthineers AG	ERLANGEN Bavaria, Germany	Manufacturer, Specification developer	0	api.fda.gov
Siemens Healthineers AG	RUDOLSTADT Thuringia, Germany	Complaint file establishment, Manufacturer	0	api.fda.gov
Source-Ray, Inc.	Ronkonkoma, NY, United States	Manufacturer	0	api.fda.gov
Spellman de Mexico Plant 3	Matamoros Tamaulipas, Mexico	Manufacturer	0	api.fda.gov
Varex Imaging Corporation	Salt Lake City, UT, United States	Manufacturer	0	api.fda.gov
Varex Imaging Equipment (China) Co., LTD	Wuxi Jiangsu, China	Contract manufacturer	0	api.fda.gov
Wuxi Guochen Medical Technology Co., Ltd.	Wuxi Jiangsu, China	Manufacturer	0	api.fda.gov
Wuxi Yushou Medical Appliances Co., Ltd	Wuxi City Jiangsu, China	Manufacturer	0	api.fda.gov
X-Cel X-Ray Corp.	Crystal Lake, IL, United States	Manufacturer	0	api.fda.gov
X-Ray America, LLC	Charleston, SC, United States	Manufacturer	0	api.fda.gov
Zhuhai Niray Photon Technology Co., Ltd.	Zhuhai Guangdong, China	Contract manufacturer, Manufacturer	0	api.fda.gov

Updated February 10, 2000. 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.