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
Nov 02, 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
258d
Cleared
Oct 29, 1998
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
Gammamed USA
Radiology
30d
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
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
Feb 09, 1995
REMOTE CONTROL RADIOISOTOPE APPLICATOR
Inter-Pal GmbH
Radiology
225d
Cleared
Nov 19, 1993
MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT
Nucletron-Oldelft Corp.
Radiology
360d
Cleared
Apr 13, 1993
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
Cook, Inc.
Radiology
260d
Cleared
Dec 17, 1992
6 FRENCH CATHETER
S. and H. Engineering, Inc.
Radiology
199d
Cleared
Nov 27, 1992
PULMOCATH INTRABRONCHIAL CATHETER
Omnitron Intl., Inc.
Radiology
966d
Cleared
Sep 25, 1992
PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM
Nucletron-Oldelft Corp.
Radiology
284d
Cleared
Aug 24, 1992
STANDARD IMAGING HDR 1000 ION CHAMBER
Standard Imaging, Inc.
Radiology
87d
Cleared
May 29, 1992
OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE
Omnitron Intl., Inc.
Radiology
116d
Cleared
Apr 06, 1992
HDRS-1 SYSTEM
Precision Radiation Measurement, Inc.
Radiology
131d
Cleared
Mar 06, 1992
OMNITRON GYN APPLICATOR SYSTEM
Omnitron Intl., Inc.
Radiology
189d
Cleared
Feb 28, 1992
RTS TECHNOLOGY MODELS 721,722,723,724
Rts Technology, Inc.
Radiology
133d
Cleared
Aug 02, 1991
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
Rts Technology, Inc.
Radiology
52d
Cleared
Oct 12, 1990
PULSED SELECTRON
Nucletron-Oldelft Corp.
Radiology
126d