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
Feb 19, 2015
Vienna System
Mick Radio-Nuclear Instruments, Inc.
Radiology
157d
Cleared
Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
Varian Medical Systems, Inc.
Radiology
113d
Cleared
Aug 06, 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
Varian Medical Systems, Inc.
Radiology
77d
Cleared
Mar 13, 2013
ESOPHAGUS BOUGIE SET
Varian Medical Systems, Inc.
Radiology
40d
Cleared
Mar 11, 2013
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
Varian Medical Systems, Inc.
Radiology
89d
Cleared
Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
Mick Radio-Nuclear Instruments, Inc.
Radiology
88d
Cleared
Nov 16, 2012
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
Varian Medical Systems, Inc.
Radiology
113d
Cleared
Jul 26, 2012
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
Varian Medical Systems, Inc.
Radiology
115d
Cleared
Jun 06, 2012
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
Varian Medical Systems, Inc.
Radiology
89d
Cleared
Apr 27, 2012
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
Varian Medical Systems, Inc.
Radiology
84d
Cleared
Mar 16, 2012
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
Varian Medical Systems, Inc.
Radiology
86d
Cleared
Nov 17, 2009
VARIAN INTERSTITIAL TITANIUM NEEDLES
Varian Medical Systems, Inc.
Radiology
27d
Cleared
Aug 27, 2009
MAMMOSITE MULTI LUMEN
Hologic, Inc.
Radiology
21d
Cleared
Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
Hologic, Inc.
Radiology
52d
Cleared
Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
Varian Medical Systems, Inc.
Radiology
28d
Cleared
May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
Hologic, Inc.
Radiology
14d
Cleared
Nov 16, 2007
INTERSTITIAL NEEDLES
Varian Medical Systems, Inc.
Radiology
9d
Cleared
Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
Varian Medical Systems, Inc.
Radiology
48d
Cleared
Dec 26, 2006
HDR CT COMPATIBLE SPLIT RING APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
48d
Cleared
Dec 22, 2006
CT COMPATIBLE F/S/D APPLICATORS
Mick Radio-Nuclear Instruments, Inc.
Radiology
44d
Cleared
Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
Varian Medical Systems, Inc.
Radiology
48d
Cleared
Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
49d
Cleared
Jul 01, 2005
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
Mick Radio-Nuclear Instruments, Inc.
Radiology
30d
Cleared
Feb 16, 2005
VARIAN NASOPHARYNX APPLICATOR
Varian Medical Systems, Inc.
Radiology
169d