Data / Medical devices / Assembly, Tube Housing, X-Ray, Diagnostic / United States
FDA-registered makers of Assembly, Tube Housing, X-Ray, Diagnostic in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Assembly, Tube Housing, X-Ray, Diagnostic (product code ITY). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Assembly, Tube Housing, X-Ray, Diagnostic
- Product code
- ITY
- Country
- United States
Makers of Assembly, Tube Housing, X-Ray, Diagnostic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amirix Imaging | Newbury Park, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chronos Imaging, LLC | Aurora, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ge Medical Systems, LLC | Milwaukee, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | Madison, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richardson Electronics | Lafox, IL, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spellman High Voltage Electronics Corp. | Hauppauge, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Source-Ray, Inc. | Ronkonkoma, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Varex Imaging Corporation | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-Cel X-Ray Corp. | Crystal Lake, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-Ray America, LLC | Charleston, SC, United States | Manufacturer | 0 | 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.