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
169–192 of 208
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
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 Feb 09, 1995
REMOTE CONTROL RADIOISOTOPE APPLICATOR
K943109
Inter-Pal GmbH
Radiology · 225d
Cleared Nov 19, 1993
MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT
K925956
Nucletron-Oldelft Corp.
Radiology · 360d
Cleared Apr 13, 1993
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
K923738
Cook, Inc.
Radiology · 260d
Cleared Dec 17, 1992
6 FRENCH CATHETER
K922564
S. and H. Engineering, Inc.
Radiology · 199d
Cleared Nov 27, 1992
PULMOCATH INTRABRONCHIAL CATHETER
K901615
Omnitron Intl., Inc.
Radiology · 966d
Cleared Sep 25, 1992
PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
K915622
Nucletron-Oldelft Corp.
Radiology · 284d
Cleared Aug 24, 1992
STANDARD IMAGING HDR 1000 ION CHAMBER
K922554
Standard Imaging, Inc.
Radiology · 87d
Cleared May 29, 1992
OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE
K920431
Omnitron Intl., Inc.
Radiology · 116d
Cleared Apr 06, 1992
HDRS-1 SYSTEM
K915367
Precision Radiation Measurement, Inc.
Radiology · 131d
Cleared Mar 06, 1992
OMNITRON GYN APPLICATOR SYSTEM
K913908
Omnitron Intl., Inc.
Radiology · 189d
Cleared Feb 28, 1992
RTS TECHNOLOGY MODELS 721,722,723,724
K914578
Rts Technology, Inc.
Radiology · 133d
Cleared Aug 02, 1991
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
K912555
Rts Technology, Inc.
Radiology · 52d
Cleared Oct 12, 1990
PULSED SELECTRON
K902533
Nucletron-Oldelft Corp.
Radiology · 126d