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