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 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
May 03, 2012
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
Radiadyne, LLC (Specification Developer)
Radiology
90d
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 18, 2011
ONCENTRA PROSTATE 4.0
Nucletron
Radiology
87d
Cleared
Sep 21, 2011
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
Nucletron
Radiology
71d
Cleared
Nov 17, 2009
VARIAN INTERSTITIAL TITANIUM NEEDLES
Varian Medical Systems, Inc.
Radiology
27d
Cleared
Oct 08, 2009
MICROSELECTRON HDR V2, MODEL 105.999
Nucletron Corp.
Radiology
27d
Cleared
Aug 27, 2009
MAMMOSITE MULTI LUMEN
Hologic, Inc.
Radiology
21d
Cleared
Aug 19, 2009
CONTURA CAVITY MAINTENANCE CATHETER
Senorx, Inc.
Radiology
15d
Cleared
Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
Hologic, Inc.
Radiology
52d
Cleared
Jun 29, 2009
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS
Nucletron Corp.
Radiology
26d
Cleared
May 18, 2009
UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
Nucletron Corporation
Radiology
27d
Cleared
Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
Varian Medical Systems, Inc.
Radiology
28d
Cleared
Sep 12, 2008
CONTURA LUMEN MARKER
Senorx, Inc.
Radiology
32d
Cleared
May 28, 2008
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
Nucletron Corporation
Radiology
56d
Cleared
May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
Hologic, Inc.
Radiology
14d
Cleared
May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
Senorx, Inc.
Radiology
16d
Cleared
Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
Senorx, Inc.
Radiology
41d
Cleared
Apr 29, 2008
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
Nucletron Corporation
Radiology
29d
Cleared
Dec 07, 2007
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
Nucletron Corporation
Radiology
35d
Cleared
Nov 16, 2007
INTERSTITIAL NEEDLES
Varian Medical Systems, Inc.
Radiology
9d