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 Alpha-Omega Services, Inc..
FDA 510(k) Cleared System, Applicator, Radionuclide, Remote-controlled Devices (Product Code JAQ)
About Product Code JAQ - Regulatory Context
510(k) Submission Activity
206 total 510(k) submissions under product code JAQ since 1978, with 206 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 13 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for JAQ submissions have been consistent, averaging 133 days recently vs 136 days historically.
JAQ devices are reviewed by the Radiology panel. Browse all Radiology devices →