Data / Medical devices / Couch, Radiation Therapy, Powered
Couch, Radiation Therapy, Powered (JAI): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Couch, Radiation Therapy, Powered (product code JAI, Class 2, 21 CFR 892.5770). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on May 7, 2024, and lists 17 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JAI
- Device class
- 2
- Regulation
- 892.5770
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 2 |
| Canada | 1 |
| France | 1 |
Makers of Couch, Radiation Therapy, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Anholt Technologies Inc. | Avondale, PA, United States | Manufacturer | 4 | September 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medtec LLC | Orange City, IA, United States | Manufacturer | 3 | September 26, 2013 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthineers AG Varian Cancer Therapy (CTH) | Erlangen Bavaria, Germany | Complaint file establishment, Specification developer | 2 | March 18, 2005 | 0 | 0 | 0 | api.fda.gov |
| 3C-Medical Intelligence GmbH | Landsberg am Lech Bavaria, Germany | Manufacturer | 1 | October 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| Aktina Medical Corp. | Congers, NY, United States | Manufacturer | 1 | January 10, 2000 | 0 | 0 | 0 | api.fda.gov |
| Best Theratronics Ltd. | Kanata Ontario, Canada | Manufacturer | 1 | May 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| BizLink Robotic Solutions France | Chartres Eure-et-Loir, France | Manufacturer | 1 | July 14, 2016 | 0 | 1 | 0 | api.fda.gov |
Updated May 7, 2024. 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.