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 Varian Medical Systems.
208
Total
208
Cleared
136d
Avg days
1978
Since
208 devices
Cleared
Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
92d
Cleared
Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
20d
Cleared
Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
Mick Radio-Nuclear Instruments, Inc.
Radiology
54d
Cleared
Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
195d
Cleared
Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
80d
Cleared
Apr 08, 2002
HDR MIAMI APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
80d
Cleared
Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
90d
Cleared
Nov 17, 2000
VAGINAL APPLICATOR SHIELDED
Mick Radio-Nuclear Instruments, Inc.
Radiology
183d
Cleared
Jan 12, 2000
SEGMENTED VAGINAL APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
90d
Cleared
Jan 06, 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
Mick Radio-Nuclear Instruments, Inc.
Radiology
90d
Cleared
May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
Cook, Inc.
Radiology
80d
Cleared
Nov 03, 1998
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
Cook, Inc.
Radiology
158d
Cleared
Nov 02, 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
258d
Cleared
Oct 22, 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
247d
Cleared
Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
Varian Assoc., Inc.
Radiology
246d
Cleared
Dec 23, 1996
H.A.M. APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
242d
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
Jan 10, 1984
MULTITREAT 48
Mick Radio-Nuclear Instruments, Inc.
Radiology
67d