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
Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
Varian Assoc., Inc.
Radiology
246d
Cleared
Mar 10, 1997
AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
Alpha-Omega Services, Inc.
Radiology
91d
Cleared
Dec 23, 1996
H.A.M. APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
242d
Cleared
Aug 13, 1996
MICROSELECTRON-HDR VERSION 2
Nucletron-Oldelft Corp.
Radiology
358d
Cleared
Jul 26, 1996
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
Varian Assoc., Inc.
Radiology
213d
Cleared
Mar 15, 1996
CADPLAN BT
Varian Assoc., Inc.
Radiology
171d
Cleared
Nov 22, 1995
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
Varian Assoc., Inc.
Radiology
149d
Cleared
Feb 15, 1995
HIGH DOSE RATE AFTERLOADER
Varian Assoc., Inc.
Radiology
113d
Cleared
Apr 13, 1993
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
Cook, Inc.
Radiology
260d
Cleared
Nov 21, 1989
GAMMAMED IRIDIUM-192 SOURCE
Mick Radio-Nuclear Instruments, Inc.
Radiology
127d
Cleared
Aug 07, 1989
GAMMAMED 12I
Mick Radio-Nuclear Instruments, Inc.
Radiology
157d
Cleared
Mar 19, 1984
CURIETRON
Syncor Intl. Corp.
Radiology
68d
Cleared
Jan 10, 1984
MULTITREAT 48
Mick Radio-Nuclear Instruments, Inc.
Radiology
67d
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