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
73–96 of 208
Cleared Nov 16, 2012
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
K122236
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Jul 26, 2012
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
K120993
Varian Medical Systems, Inc.
Radiology · 115d
Cleared Jun 06, 2012
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
K120731
Varian Medical Systems, Inc.
Radiology · 89d
Cleared May 03, 2012
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
K120344
Radiadyne, LLC (Specification Developer)
Radiology · 90d
Cleared Apr 27, 2012
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
K120341
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
K113766
Varian Medical Systems, Inc.
Radiology · 86d
Cleared Nov 18, 2011
ONCENTRA PROSTATE 4.0
K112420
Nucletron
Radiology · 87d
Cleared Sep 21, 2011
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
K111973
Nucletron
Radiology · 71d
Cleared Nov 17, 2009
VARIAN INTERSTITIAL TITANIUM NEEDLES
K093291
Varian Medical Systems, Inc.
Radiology · 27d
Cleared Oct 08, 2009
MICROSELECTRON HDR V2, MODEL 105.999
K092804
Nucletron Corp.
Radiology · 27d
Cleared Aug 27, 2009
MAMMOSITE MULTI LUMEN
K092405
Hologic, Inc.
Radiology · 21d
Cleared Aug 19, 2009
CONTURA CAVITY MAINTENANCE CATHETER
K092323
Senorx, Inc.
Radiology · 15d
Cleared Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
K091378
Hologic, Inc.
Radiology · 52d
Cleared Jun 29, 2009
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS
K091598
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,
K091154
Nucletron Corporation
Radiology · 27d
Cleared Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
K082653
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Sep 12, 2008
CONTURA LUMEN MARKER
K082264
Senorx, Inc.
Radiology · 32d
Cleared May 28, 2008
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
K080934
Nucletron Corporation
Radiology · 56d
Cleared May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179
Hologic, Inc.
Radiology · 14d
Cleared May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
K081079
Senorx, Inc.
Radiology · 16d
Cleared Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
K080791
Senorx, Inc.
Radiology · 41d
Cleared Apr 29, 2008
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
K080871
Nucletron Corporation
Radiology · 29d
Cleared Dec 07, 2007
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
K073107
Nucletron Corporation
Radiology · 35d
Cleared Nov 16, 2007
INTERSTITIAL NEEDLES
K073133
Varian Medical Systems, Inc.
Radiology · 9d