JAQ · Class II · 21 CFR 892.5700

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., Mick Radio-Nuclear Instruments, Inc. and Nucletron Corp..

208
Total
208
Cleared
136d
Avg days
1978
Since
208 devices
193–208 of 208
Cleared Aug 17, 1990
RTS TECHNOLOGY IRIDIUM 192 SOURCES
K901589
Rts Technology, Inc.
Radiology · 143d
Cleared Feb 01, 1990
INTER-PAL C-19 AND INTER-PAL C-38
K890294
Enrad Corp.
Radiology · 378d
Cleared Nov 21, 1989
GAMMAMED IRIDIUM-192 SOURCE
K894381
Mick Radio-Nuclear Instruments, Inc.
Radiology · 127d
Cleared Oct 27, 1989
CURIETRON 192 HIGH DOSE RATE
K890799
Cis-Us, Inc.
Radiology · 252d
Cleared Aug 07, 1989
GAMMAMED 12I
K891131
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Jan 17, 1989
CURIETRON 192 LOW DOSE RATE
K881323
Compagnie Oris Industrie, S.A.
Radiology · 295d
Cleared Aug 11, 1988
OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR
K881665
Omnitron Intl., Inc.
Radiology · 115d
Cleared Nov 26, 1986
MICROSELECTRON-HDR (HIGH DOSE RATE)
K864210
Nucletron-Oldelft Corp.
Radiology · 29d
Cleared May 21, 1986
MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS
K853912
Nucletron-Oldelft Corp.
Radiology · 243d
Cleared Jan 10, 1986
SELECTRON HDR REMOTE AFTERLOADER
K852842
Nucletron-Oldelft Corp.
Radiology · 189d
Cleared Feb 26, 1985
SELECTRON LDR SELECTRON LOW DOSE RATE
K844714
Radiochemical Co.
Radiology · 85d
Cleared Mar 19, 1984
CURIETRON
K840127
Syncor Intl. Corp.
Radiology · 68d
Cleared Jan 10, 1984
MULTITREAT 48
K834308
Mick Radio-Nuclear Instruments, Inc.
Radiology · 67d
Cleared Sep 29, 1983
AFTER LOADING BUCHLER
K832789
Ellis Pharmaceutical Consulting, Inc.
Radiology · 45d
Cleared Feb 02, 1981
SELECTRON REMOTE ISOTOPE
K810051
Victoreen, Inc.
Radiology · 34d
Cleared Aug 10, 1978
GAMMA MED II
K781274
Mick Radio-Nuclear Instruments, Inc.
Radiology · 17d