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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

CountryMakers
United States17
Germany3
Netherlands2
Costa Rica2
Switzerland2
Sweden1
Czechia1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Varian Medical Systems Haan GmbHHaan North Rhine-Westphalia, GermanyComplaint file establishment, Manufacturer48May 20, 2026000api.fda.gov
Nucletron B.V.VEENENDAAL Utrecht, NetherlandsExporter to the US, Manufacturer, Specification developer28July 24, 2026010api.fda.gov
Mick Radio-Nuclear Instruments, Inc.Mount Vernon, NY, United StatesManufacturer17August 30, 2023000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer10August 27, 2009000api.fda.gov
Hologic Surgical Products Costa Rica, S.R.L.El Coyol Alajuela, Costa RicaManufacturer5August 27, 2009000api.fda.gov
Alpha-Omega Services, Inc.Bellflower, CA, United StatesComplaint file establishment, Manufacturer3July 10, 2024010api.fda.gov
Best Medical International, Inc.Springfield, VA, United StatesManufacturer, Repackager or relabeler3April 13, 2018000api.fda.gov
Elekta Solutions ABStockholm, SwedenSpecification developer2July 16, 2020000api.fda.gov
Merit Medical Systems, Inc.Aliso Viejo, CA, United StatesSpecification developer2July 12, 2010000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer2April 11, 2006000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer1December 7, 2009000api.fda.gov
Bebig Medical GMBHBerlin, GermanyManufacturer1April 17, 2015000api.fda.gov
C4 Imaging LLCBellaire, TX, United StatesSpecification developer1April 27, 2018000api.fda.gov
Geomed Medizin-Technik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1July 10, 2020000api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer1November 7, 2006000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1February 19, 2015000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1February 19, 2015000api.fda.gov
Alpha-Omega Services, Inc.Vinton, LA, United StatesContract manufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Biomerics CartagoCartago, Costa RicaContract manufacturer0000api.fda.gov
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer, Specification developer0000api.fda.gov
Contract Medical International, Spol. S R.O.Hradec Kralove, CzechiaContract manufacturer0000api.fda.gov
Curium Netherlands B.V.Petten Noord-Holland, NetherlandsContract manufacturer0000api.fda.gov
Dupaco, Inc.Oceanside, CA, United StatesContract manufacturer0000api.fda.gov
Elekta Inc.San Jose, CA, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Mirion Technologies (capintec), IncFlorham Park, NJ, United StatesManufacturer0000api.fda.gov
Tecma Operaciones S. De R.L. De C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.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.