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 Varian Medical Systems.

208
Total
208
Cleared
136d
Avg days
1978
Since
208 devices
49–72 of 208
Cleared Feb 19, 2015
Vienna System
K142597
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Aug 06, 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
K141336
Varian Medical Systems, Inc.
Radiology · 77d
Cleared Mar 13, 2013
ESOPHAGUS BOUGIE SET
K130251
Varian Medical Systems, Inc.
Radiology · 40d
Cleared Mar 11, 2013
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
K123815
Varian Medical Systems, Inc.
Radiology · 89d
Cleared Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
K122840
Mick Radio-Nuclear Instruments, Inc.
Radiology · 88d
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 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 17, 2009
VARIAN INTERSTITIAL TITANIUM NEEDLES
K093291
Varian Medical Systems, Inc.
Radiology · 27d
Cleared Aug 27, 2009
MAMMOSITE MULTI LUMEN
K092405
Hologic, Inc.
Radiology · 21d
Cleared Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
K091378
Hologic, Inc.
Radiology · 52d
Cleared Oct 10, 2008
CENTERING INTRALUMINAL APPLICATOR
K082653
Varian Medical Systems, Inc.
Radiology · 28d
Cleared May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179
Hologic, Inc.
Radiology · 14d
Cleared Nov 16, 2007
INTERSTITIAL NEEDLES
K073133
Varian Medical Systems, Inc.
Radiology · 9d
Cleared Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
K071467
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Dec 26, 2006
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382
Mick Radio-Nuclear Instruments, Inc.
Radiology · 48d
Cleared Dec 22, 2006
CT COMPATIBLE F/S/D APPLICATORS
K063381
Mick Radio-Nuclear Instruments, Inc.
Radiology · 44d
Cleared Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
K061582
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
K052351
Mick Radio-Nuclear Instruments, Inc.
Radiology · 49d
Cleared Jul 01, 2005
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
K051423
Mick Radio-Nuclear Instruments, Inc.
Radiology · 30d
Cleared Feb 16, 2005
VARIAN NASOPHARYNX APPLICATOR
K042360
Varian Medical Systems, Inc.
Radiology · 169d