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Data / Medical devices / Solid State X-Ray Imager (Flat Panel/Digital Imager) / United States

FDA-registered makers of Solid State X-Ray Imager (Flat Panel/Digital Imager) in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Solid State X-Ray Imager (Flat Panel/Digital Imager) (product code MQB). 14 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Product code
MQB
Country
United States

Makers of Solid State X-Ray Imager (Flat Panel/Digital Imager) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Carestream Health, IncRochester, NY, United StatesComplaint file establishment, Manufacturer11October 9, 2025010api.fda.gov
Compass Innovations, IncSanta Clara, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler10December 30, 2022000api.fda.gov
Konica Minolta Healthcare Americas, IncGarner, NC, United StatesManufacturer6June 12, 2026000api.fda.gov
Radlink, Inc.El Segundo, CA, United StatesManufacturer, Repackager or relabeler4September 8, 2016000api.fda.gov
Varex Imaging CorporationSalt Lake City, UT, United StatesManufacturer4December 20, 2019000api.fda.gov
iCRco Inc.Goleta, CA, United StatesManufacturer, Repackager or relabeler3July 20, 2022000api.fda.gov
Biokinemetrics Inc.Carroll, IA, United StatesManufacturer2March 13, 2019000api.fda.gov
Del Medical, Inc.Bloomingdale, IL, United StatesManufacturer2July 17, 2014000api.fda.gov
Kub Technologies, Inc.Stratford, CT, United StatesManufacturer2June 23, 2015000api.fda.gov
RadmediX, LLCDayton, OH, United StatesManufacturer, Repackager or relabeler2July 12, 2023000api.fda.gov
Aspen Imaging Healthcare, IncPlano, TX, United StatesManufacturer1February 14, 2020000api.fda.gov
First Source Inc.Rochester, NY, United StatesSpecification developer1March 24, 2021000api.fda.gov
Ge Medical Systems, LLCWaukesha, WI, United StatesManufacturer, Specification developer1November 17, 20060300api.fda.gov
Medicatech UsaAnaheim, CA, United StatesManufacturer, Repackager or relabeler, Specification developer1September 1, 2023000api.fda.gov
Accogent PauschEatontown, NJ, United StatesManufacturer0000api.fda.gov
Dentsply LLCYork, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Iray Imaging LLCSolon, OH, United StatesContract manufacturer0000api.fda.gov
Minxray, Inc.Northbrook, IL, United StatesManufacturer0000api.fda.gov
Omega Medical Imaging, LLCSanford, FL, United StatesManufacturer0000api.fda.gov
Orthoscan, Inc.Scottsdale, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Radiology Information Systems, Inc.Dulles, VA, United StatesManufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Summit Industries, LLCNiles, IL, United StatesManufacturer0000api.fda.gov
Source-Ray, Inc.Ronkonkoma, NY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Zentech Manufacturing, IncBaltimore, MD, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.