Data / Medical devices / Image-Intensified Fluoroscopic X-Ray System, Mobile / United States
FDA-registered makers of Image-Intensified Fluoroscopic X-Ray System, Mobile in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Image-Intensified Fluoroscopic X-Ray System, Mobile (product code OXO). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Product code
- OXO
- Country
- United States
Makers of Image-Intensified Fluoroscopic X-Ray System, Mobile in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Orthoscan, Inc. | Scottsdale, AZ, United States | Complaint file establishment, Manufacturer | 8 | January 14, 2026 | 0 | 1 | 0 | api.fda.gov |
| Ge Oec Medical Systems, Inc | Salt Lake City, UT, United States | Manufacturer, Manufacturer for export | 7 | March 28, 2024 | 0 | 14 | 2 | api.fda.gov |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer | 3 | June 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| MEDTRONIC NAVIGATION, INC. (Boxborough) | Boxborough, MA, United States | Remanufacturer, Specification developer | 3 | June 17, 2010 | 0 | 7 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 1 | April 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Marlborough, MA, United States | Specification developer | 1 | April 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Turner Imaging Systems, Inc. | Orem, UT, United States | Manufacturer | 1 | September 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Aspen Imaging Healthcare, Inc | Plano, TX, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Methuen, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imaging Engineering, LLC | Gainesville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nview Medical | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxos Medical, Inc | Atlanta, GA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xoran Technologies, LLC | Ann Arbor, MI, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.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.