Data / Medical devices / System, X-Ray, Fluoroscopic, Image-Intensified / United States

FDA-registered makers of System, X-Ray, Fluoroscopic, Image-Intensified in the United States: 35 establishments

Name: FDA-registered makers of System, X-Ray, Fluoroscopic, Image-Intensified in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

35 establishments in the United States are registered with the FDA to make System, X-Ray, Fluoroscopic, Image-Intensified (product code JAA). 10 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device: System, X-Ray, Fluoroscopic, Image-Intensified
Product code: JAA
Country: United States

Makers of System, X-Ray, Fluoroscopic, Image-Intensified in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Omega Medical Imaging, LLC	Sanford, FL, United States	Manufacturer, Specification developer	4	January 6, 2025	0	0	api.fda.gov
Ge Medical Systems, LLC	Waukesha, WI, United States	Manufacturer	3	June 11, 2008	21	0	api.fda.gov
Imaging Engineering, LLC	Gainesville, FL, United States	Manufacturer	3	September 16, 2025	0	0	api.fda.gov
Advance Medical Designs, Inc.	Marietta, GA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	1	April 9, 1985	1	0	api.fda.gov
DMX Imaging, LLC	Palm Harbor, FL, United States	Manufacturer	1	December 27, 1994	0	0	api.fda.gov
Ge Oec Medical Systems, Inc	Salt Lake City, UT, United States	Manufacturer	1	March 20, 2003	27	1	api.fda.gov
Hologic, Inc.	Newark, DE, United States	Complaint file establishment, Manufacturer	1	May 13, 2005	0	0	api.fda.gov
Preferred Medical Products, LLC	Copperhill, TN, United States	Manufacturer	1	March 6, 1987	0	0	api.fda.gov
Radiology Information Systems, Inc.	Dulles, VA, United States	Manufacturer	1	August 16, 2019	0	0	api.fda.gov
Varex Imaging Corporation	Salt Lake City, UT, United States	Manufacturer	1	April 22, 2013	0	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Aspen Imaging Healthcare, Inc	Plano, TX, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Accogent Pausch	Eatontown, NJ, United States	Manufacturer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Compass Innovations, Inc	Santa Clara, CA, United States	Manufacturer, Remanufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Methuen, MA, United States	Manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	0	api.fda.gov
Medtronic Navigation, Inc.	Lafayette, CO, United States	Manufacturer	0		0	0	api.fda.gov
MEDTRONIC NAVIGATION, INC. (Boxborough)	Boxborough, MA, United States	Remanufacturer, Specification developer	0		1	0	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	0		0	0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Nview Medical	Salt Lake City, UT, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Orthoscan, Inc.	Scottsdale, AZ, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	0	api.fda.gov
Spectrum Assembly Inc.	Carlsbad, CA, United States	Contract manufacturer	0		0	0	api.fda.gov
Spartronics Watertown LLC	Watertown, SD, United States	Contract manufacturer	0		0	0	api.fda.gov
TRACKX TECHNOLOGY Inc.	Hillsborough, NC, United States	Manufacturer	0		0	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Turner Imaging Systems, Inc.	Orem, UT, United States	Manufacturer	0		0	0	api.fda.gov
Wheelhouse Medical	Monroe, NC, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated November 3, 2026. 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.