Data / Medical devices / Tube Mount, X-Ray, Diagnostic

Tube Mount, X-Ray, Diagnostic (IYB): 28 FDA-registered makers in 10 countries

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

28 establishments in 10 countries are registered with the FDA to make Tube Mount, X-Ray, Diagnostic (product code IYB, Class 1, 21 CFR 892.1770). 1 of them has a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on March 27, 1996, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: IYB
Device class: 1
Regulation: 892.1770
Medical specialty: Radiology

Makers by country

Country	Makers
United States	8
South Korea	5
China	4
Germany	3
Mexico	2
Japan	2
Sweden	1
Netherlands	1
Spain	1
Canada	1

Makers of Tube Mount, 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	Recall events	Source
Accogent Pausch	Eatontown, NJ, United States	Manufacturer	1	March 30, 1987	0	api.fda.gov
Air Techniques, Inc.	Melville, NY, United States	Manufacturer	0		0	api.fda.gov
Arcoma AB	VAXJO Kronoberg, Sweden	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Aspen Imaging Healthcare, Inc	Plano, TX, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Carestream Health, Inc., Global R&D Center	Shanghai, China	Specification developer	0		0	api.fda.gov
Compania Mexicana De Radiologia CGR, S.A. De C.V.	Queretaro, Mexico	Manufacturer	0		0	api.fda.gov
Core Labs, LLC.	Englewood, CO, United States	Manufacturer	0		0	api.fda.gov
Del Medical, Inc.	Bloomingdale, IL, United States	Manufacturer	0		3	api.fda.gov
DK Medical Systems Co., Ltd.	Pyeongtaek-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Drgem Corporation	Gwangmyeong-si Gyeongbuk, South Korea	Complaint file establishment, Specification developer	0		0	api.fda.gov
DRGEM Corporation (Gimcheon Factory)	Gimcheon-si Gyeongbuk, South Korea	Manufacturer	0		0	api.fda.gov
ECOTRON Co., Ltd.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Ge Hangwei Medical Systems Co., Ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
GE Healthcare (China) Co., Ltd.	Beijing, China	Specification developer	0		0	api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.	APODACA Nuevo Leon, Mexico	Manufacturer	0		0	api.fda.gov
Livermoretech,inc	Plano, TX, United States	Manufacturer	0		0	api.fda.gov
Oxos Medical, Inc	Atlanta, GA, United States	Manufacturer	0		0	api.fda.gov
PAUSCH Medical GmbH	ERLANGEN Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Philips Medical Systems Nederland B.V.	BEST Noord-Brabant, Netherlands	Contract manufacturer	0		0	api.fda.gov
Philips Medical Systems DMC GmbH	Hamburg, Germany	Complaint file establishment, Specification developer	0		0	api.fda.gov
Sedecal S.A.	ALGETE Madrid(Province), Spain	Manufacturer	0		0	api.fda.gov
Shimadzu Corporation Medical Systems Division	Kyoto, Japan	Manufacturer	0		2	api.fda.gov
Shimane Shimadzu Corporation	IZUMO Shimane, Japan	Manufacturer	0		0	api.fda.gov
Shinyoung For M Co., Ltd.	Namyangju-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Summit Industries, LLC	Niles, IL, United States	Complaint file establishment, Manufacturer	0		1	api.fda.gov
Siemens Healthineers AG	KEMNATH Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Upper Cervical Store, Inc.	Calgary Alberta, Canada	Manufacturer	0		0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	0		0	api.fda.gov

Updated March 27, 1996. 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.