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 Varian Medical Systems.

208
Total
208
Cleared
136d
Avg days
1978
Since
208 devices
73–96 of 208
Cleared Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
K040704
Mick Radio-Nuclear Instruments, Inc.
Radiology · 92d
Cleared Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
K040541
Varian Medical Systems, Inc.
Radiology · 20d
Cleared Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
K033828
Mick Radio-Nuclear Instruments, Inc.
Radiology · 54d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524
Varian Medical Systems, Inc.
Radiology · 195d
Cleared Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K030110
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 08, 2002
HDR MIAMI APPLICATOR
K020176
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Nov 17, 2000
VAGINAL APPLICATOR SHIELDED
K001544
Mick Radio-Nuclear Instruments, Inc.
Radiology · 183d
Cleared Jan 12, 2000
SEGMENTED VAGINAL APPLICATOR
K993472
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Jan 06, 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
K993400
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753
Cook, Inc.
Radiology · 80d
Cleared Nov 03, 1998
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K981886
Cook, Inc.
Radiology · 158d
Cleared Nov 02, 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980576
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Oct 22, 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980590
Varian Medical Systems, Inc.
Radiology · 247d
Cleared Oct 21, 1998
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER
K980601
Varian Assoc., Inc.
Radiology · 246d
Cleared Dec 23, 1996
H.A.M. APPLICATOR
K961601
Mick Radio-Nuclear Instruments, Inc.
Radiology · 242d
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 Jan 10, 1984
MULTITREAT 48
K834308
Mick Radio-Nuclear Instruments, Inc.
Radiology · 67d