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
145–168 of 208
Cleared Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
K980601
Varian Assoc., Inc.
Radiology · 246d
Cleared Mar 10, 1997
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
K964910
Alpha-Omega Services, Inc.
Radiology · 91d
Cleared Dec 23, 1996
H.A.M. APPLICATOR
K961601
Mick Radio-Nuclear Instruments, Inc.
Radiology · 242d
Cleared Aug 13, 1996
MICROSELECTRON-HDR VERSION 2
K953946
Nucletron-Oldelft Corp.
Radiology · 358d
Cleared Jul 26, 1996
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K955844
Varian Assoc., Inc.
Radiology · 213d
Cleared Mar 15, 1996
CADPLAN BT
K954467
Varian Assoc., Inc.
Radiology · 171d
Cleared Nov 22, 1995
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
K952913
Varian Assoc., Inc.
Radiology · 149d
Cleared Feb 15, 1995
HIGH DOSE RATE AFTERLOADER
K945383
Varian Assoc., Inc.
Radiology · 113d
Cleared Apr 13, 1993
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
K923738
Cook, Inc.
Radiology · 260d
Cleared Nov 21, 1989
GAMMAMED IRIDIUM-192 SOURCE
K894381
Mick Radio-Nuclear Instruments, Inc.
Radiology · 127d
Cleared Aug 07, 1989
GAMMAMED 12I
K891131
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
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 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