Data / Medical devices / Table, Radiographic, Tilting

Table, Radiographic, Tilting (IXR): 18 FDA-registered makers in 9 countries

Name: FDA-registered makers of Table, Radiographic, Tilting
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 9 countries are registered with the FDA to make Table, Radiographic, Tilting (product code IXR, Class 2, 21 CFR 892.1980). 1 of them has a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 77 510(k) clearances under this code, the latest on April 24, 2000, and lists 23 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: IXR
Device class: 2
Regulation: 892.1980
Medical specialty: Radiology

Makers by country

Country	Makers
Sweden	3
United States	3
India	3
Germany	2
China	2
Japan	2
South Korea	1
Canada	1
United Kingdom	1

Makers of Table, Radiographic, Tilting

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
Philips Medical Systems DMC GmbH	Hamburg, Germany	Complaint file establishment, Specification developer	1	March 21, 1997	0	api.fda.gov
Arcoma AB	VAXJO Kronoberg, Sweden	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Accogent Pausch	Eatontown, NJ, United States	Manufacturer	0		0	api.fda.gov
CBH Inc	Jeonju-si Jeonbuk, 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
Greens Surgicals Private Limited	Vadodara Gujarat, India	Manufacturer	0		0	api.fda.gov
Image Diagnostics, Inc.	Fitchburg, MA, United States	Manufacturer	0		0	api.fda.gov
Oakworks, Inc.	New Freedom, PA, United States	Manufacturer	0		2	api.fda.gov
Octostop, Inc.	LAVAL Quebec, Canada	Manufacturer	0		0	api.fda.gov
PAUSCH Medical GmbH	ERLANGEN Bavaria, Germany	Manufacturer	0		0	api.fda.gov
Philips India Limited - Diagnostic X-ray Business Unit	Bengaluru Karnataka, India	Specification developer	0		0	api.fda.gov
Philips India Limited - Diagnostic X-ray Business Unit	Pimpri Maharashtra, India	Specification developer	0		0	api.fda.gov
Samhall AB	Svenstavik Jamtland, Sweden	Contract manufacturer	0		0	api.fda.gov
Shimadzu Corporation Medical Systems Division	Kyoto, Japan	Manufacturer	0		0	api.fda.gov
Shimane Shimadzu Corporation	IZUMO Shimane, Japan	Manufacturer	0		0	api.fda.gov
Sonesta Medical AB	Stockholm, Sweden	Exporter to the US, Manufacturer, Specification developer	0		1	api.fda.gov
Wardray Premise Ltd	Brighouse Leeds, United Kingdom	Manufacturer	0		0	api.fda.gov

Updated April 24, 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.