Data / Medical devices / System, Applicator, Radionuclide, Remote-Controlled
System, Applicator, Radionuclide, Remote-Controlled (JAQ): 29 FDA-registered makers in 8 countries
29 establishments in 8 countries are registered with the FDA to make System, Applicator, Radionuclide, Remote-Controlled (product code JAQ, Class 2, 21 CFR 892.5700). 17 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 208 510(k) clearances under this code, the latest on July 24, 2026, and lists 27 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JAQ
- Device class
- 2
- Regulation
- 892.5700
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 17 |
| Germany | 3 |
| Netherlands | 2 |
| Costa Rica | 2 |
| Switzerland | 2 |
| Sweden | 1 |
| Czechia | 1 |
| Mexico | 1 |
Makers of System, Applicator, Radionuclide, Remote-Controlled
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 |
|---|---|---|---|---|---|---|---|---|
| Varian Medical Systems Haan GmbH | Haan North Rhine-Westphalia, Germany | Complaint file establishment, Manufacturer | 48 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nucletron B.V. | VEENENDAAL Utrecht, Netherlands | Exporter to the US, Manufacturer, Specification developer | 28 | July 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| 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 |
| Hologic Surgical Products Costa Rica, S.R.L. | El Coyol Alajuela, Costa Rica | Manufacturer | 5 | 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 |
| Elekta Solutions AB | Stockholm, Sweden | Specification developer | 2 | July 16, 2020 | 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 |
| Bebig Medical GMBH | Berlin, Germany | Manufacturer | 1 | April 17, 2015 | 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 |
| Geomed Medizin-Technik GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | July 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 1 | November 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | February 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | February 19, 2015 | 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 | |
| Biomerics Cartago | Cartago, Costa Rica | 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 | |
| Contract Medical International, Spol. S R.O. | Hradec Kralove, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curium Netherlands B.V. | Petten Noord-Holland, Netherlands | Contract manufacturer | 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 | |
| Tecma Operaciones S. De R.L. De C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 24, 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.