Data / Medical devices / Block, Beam-Shaping, Radiation Therapy
Block, Beam-Shaping, Radiation Therapy (IXI): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Block, Beam-Shaping, Radiation Therapy (product code IXI, Class 2, 21 CFR 892.5710). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 51 510(k) clearances under this code, the latest on April 6, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IXI
- Device class
- 2
- Regulation
- 892.5710
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Sweden | 1 |
| Germany | 1 |
| Spain | 1 |
Makers of Block, Beam-Shaping, Radiation Therapy
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 |
|---|---|---|---|---|---|---|---|---|
| CQ Decimal, LLC | Sanford, FL, United States | Manufacturer | 7 | October 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Aktina Medical Corp. | Congers, NY, United States | Manufacturer | 2 | February 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 2 | May 31, 1990 | 0 | 0 | 0 | api.fda.gov |
| Elekta Solutions AB | Stockholm, Sweden | Specification developer | 1 | June 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Manufacturer | 1 | March 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Myrava, LLC | Indianapolis, IN, United States | Manufacturer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Myrava, LLC | Winston Salem, NC, United States | Manufacturer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Myrava, LLC | Parma, OH, United States | Manufacturer | 1 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG Varian Cancer Therapy (CTH) | Erlangen Bavaria, Germany | Specification developer | 1 | October 2, 2003 | 0 | 0 | 0 | api.fda.gov |
| VHA Office of Advanced Manufacturing - Ft. Lawton | Seattle, WA, United States | Manufacturer | 1 | November 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Anatomical Geometry S.L. | MAIRENA DEL ALJARAFE Sevilla, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elekta Inc. | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 6, 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.