Data / Medical devices / System, X-Ray, Stationary / United States
FDA-registered makers of System, X-Ray, Stationary in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make System, X-Ray, Stationary (product code KPR). 17 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, X-Ray, Stationary
- Product code
- KPR
- Country
- United States
Makers of System, X-Ray, Stationary in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Konica Minolta Healthcare Americas, Inc | Garner, NC, United States | Manufacturer | 6 | July 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medicatech Usa | Anaheim, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | April 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| RadmediX, LLC | Dayton, OH, United States | Manufacturer | 2 | October 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Summit Industries, LLC | Niles, IL, United States | Manufacturer | 2 | February 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| X-Cel X-Ray Corp. | Crystal Lake, IL, United States | Manufacturer | 2 | February 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Aspen Imaging Healthcare, Inc | Plano, TX, United States | Manufacturer | 1 | May 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Accogent Pausch | Eatontown, NJ, United States | Manufacturer | 1 | April 26, 1979 | 0 | 0 | 0 | api.fda.gov |
| Biokinemetrics Inc. | Carroll, IA, United States | Manufacturer | 1 | August 25, 2009 | 0 | 0 | 0 | api.fda.gov |
| Cuattro Imaging, LLC | Avon, CO, United States | Complaint file establishment, Manufacturer | 1 | October 6, 2016 | 0 | 1 | 0 | api.fda.gov |
| Carestream Health, Inc | Rochester, NY, United States | Manufacturer | 1 | January 20, 2026 | 0 | 6 | 0 | api.fda.gov |
| Del Medical, Inc. | Bloomingdale, IL, United States | Manufacturer | 1 | April 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer | 1 | August 9, 2005 | 0 | 22 | 0 | api.fda.gov |
| Kub Technologies, Inc. | Stratford, CT, United States | Manufacturer | 1 | January 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| Owo Imaging LLC | Miami, FL, United States | Complaint file establishment, Manufacturer for export, Repackager or relabeler | 1 | November 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 1 | July 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Source-Ray, Inc. | Ronkonkoma, NY, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | January 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Xoran Technologies, LLC | Ann Arbor, MI, United States | Complaint file establishment, Manufacturer, Remanufacturer | 1 | November 20, 2020 | 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.