Data / Medical devices / System, Therapeutic, X-Ray / United States
FDA-registered makers of System, Therapeutic, X-Ray in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make System, Therapeutic, X-Ray (product code JAD). 5 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
- System, Therapeutic, X-Ray
- Product code
- JAD
- Country
- United States
Makers of System, Therapeutic, X-Ray in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sensus Healthcare | Boca Raton, FL, United States | Complaint file establishment, Specification developer | 3 | March 23, 2018 | 0 | 1 | 0 | api.fda.gov |
| Empyrean Medical Systems, Inc. | Boca Raton, FL, United States | Specification developer | 2 | February 21, 2019 | 0 | 0 | 0 | api.fda.gov |
| Action Products, Inc. | Hagerstown, MD, United States | Manufacturer | 1 | July 10, 1981 | 0 | 1 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 1 | November 29, 1990 | 0 | 0 | 0 | api.fda.gov |
| Voxel Ray Solutions, LLC | Burr Ridge, IL, United States | Specification developer | 1 | December 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Elekta Inc. | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabtech Precision Sheet Metal, LLC | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koplak Corp | Sunrise, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RBM Services, LLC. | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stellartech Research Corp. | Milpitas, CA, United States | Contract manufacturer | 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.