FDA Product Code JAQ: System, Applicator, Radionuclide, Remote-controlled
FDA product code JAQ covers remote-controlled radionuclide applicator systems, also known as high-dose rate (HDR) brachytherapy afterloaders.
These systems use a computer-controlled mechanism to deliver a radioactive source to precise positions within the body via implanted catheters or applicators. They are used in the treatment of cervical, prostate, breast, and other cancers with targeted internal radiation.
JAQ devices are Class II medical devices, regulated under 21 CFR 892.5700 and reviewed by the FDA Radiology panel.
Leading manufacturers include Varian Medical Systems, Inc., Varian Medical Systems and Mick Radio-Nuclear Instruments, Inc..
List of System, Applicator, Radionuclide, Remote-controlled devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Applicator, Radionuclide, Remote-controlled devices (product code JAQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →