Data / Medical devices / System, Radiation Therapy, Radionuclide
System, Radiation Therapy, Radionuclide (IWB): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make System, Radiation Therapy, Radionuclide (product code IWB, Class 2, 21 CFR 892.5750). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on July 2, 2025, and lists 23 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IWB
- Device class
- 2
- Regulation
- 892.5750
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Canada | 1 |
| Sweden | 1 |
Makers of System, Radiation Therapy, Radionuclide
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 |
|---|---|---|---|---|---|---|---|---|
| Best Theratronics Ltd. | Kanata Ontario, Canada | Manufacturer | 3 | April 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Elekta Solutions AB | Stockholm, Sweden | Manufacturer | 3 | July 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co. | SHENZHEN Guangdong, China | Manufacturer | 2 | March 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Our SMD Medical (wuhan) Co., Ltd. | Wuhan Hubei, China | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 2 | February 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Akesis Inc. | Concord, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 1 | March 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Our United Corporation | Xian Shaanxi, China | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 1 | March 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Sun Nuclear Corporation | Melbourne, FL, United States | Manufacturer | 1 | November 5, 1991 | 0 | 0 | 0 | api.fda.gov |
| Xcision Medical Systems, LLC | Columbia, MD, United States | Manufacturer | 1 | April 4, 2018 | 0 | 2 | 0 | api.fda.gov |
| Prowess, Inc. | Concord, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 2025. 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.