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
121–144 of 208
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158
Nucletron Corp.
Radiology · 118d
Cleared Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K030110
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Oct 25, 2002
REAL TIME HDR (220V), MODEL 132.001
K022739
Nucletron Corporation
Radiology · 67d
Cleared Oct 25, 2002
VARISOURCE BREAST TEMPLATE SYSTEM
K023220
Varian Medical Systems
Radiology · 28d
Cleared Sep 06, 2002
KUSKE BREAST APPLICATOR SET, MODEL 189.006
K022635
Nucletron Corporation
Radiology · 29d
Cleared May 23, 2002
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
K021286
Nucletron Corp.
Radiology · 30d
Cleared Apr 08, 2002
HDR MIAMI APPLICATOR
K020176
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Mar 13, 2002
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
K020015
Nucletron Corp.
Radiology · 69d
Cleared Oct 17, 2001
SEED SELECTRON MODEL V. 1.0
K010032
Nucletron Corp.
Radiology · 287d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Dec 22, 2000
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270
Nucletron Corp.
Radiology · 65d
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 Oct 07, 1999
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
K990990
Nucletron Corp.
Radiology · 197d
Cleared May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753
Cook, Inc.
Radiology · 80d
Cleared Apr 20, 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338
Nucletron Corp.
Radiology · 209d
Cleared Apr 15, 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE
K983341
Nucletron Corp.
Radiology · 204d
Cleared Apr 02, 1999
TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
K983115
Nucletron Corp.
Radiology · 210d
Cleared Apr 02, 1999
ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
K983337
Nucletron Corp.
Radiology · 191d
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 29, 1998
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
K983436
Gammamed USA
Radiology · 30d
Cleared Oct 22, 1998
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980590
Varian Medical Systems, Inc.
Radiology · 247d