Data / Medical devices / System, Applicator, Radionuclide, Remote-Controlled / United States
FDA-registered makers of System, Applicator, Radionuclide, Remote-Controlled in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make System, Applicator, Radionuclide, Remote-Controlled (product code JAQ). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- System, Applicator, Radionuclide, Remote-Controlled
- Product code
- JAQ
- Country
- United States
Makers of System, Applicator, Radionuclide, Remote-Controlled in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mick Radio-Nuclear Instruments, Inc. | Mount Vernon, NY, United States | Manufacturer | 17 | August 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Marlborough, MA, United States | Complaint file establishment, Specification developer | 10 | August 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Alpha-Omega Services, Inc. | Bellflower, CA, United States | Complaint file establishment, Manufacturer | 3 | July 10, 2024 | 0 | 1 | 0 | api.fda.gov |
| Best Medical International, Inc. | Springfield, VA, United States | Manufacturer, Repackager or relabeler | 3 | April 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | Aliso Viejo, CA, United States | Specification developer | 2 | July 12, 2010 | 0 | 0 | 0 | api.fda.gov |
| Standard Imaging, Inc. | Middleton, WI, United States | Manufacturer | 2 | April 11, 2006 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 1 | December 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| C4 Imaging LLC | Bellaire, TX, United States | Specification developer | 1 | April 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 1 | November 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Alpha-Omega Services, Inc. | Vinton, LA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CIVCO Medical Instruments Co., Inc. | Coralville, IA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dupaco, Inc. | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elekta Inc. | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | 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.