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
97–120 of 208
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 Apr 04, 2008
MODIFICATION TO: SAVI APPLICATOR KIT
K080565
Cianna Medical, Inc.
Radiology · 35d
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
Cleared Jul 18, 2007
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
K071381
Varian Medical Systems
Radiology · 62d
Cleared Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
K071467
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jul 03, 2007
AOS UNIVERSAL CONECTING GUIDE TUBE
K062824
Alpha-Omega Services, Inc.
Radiology · 286d
Cleared May 29, 2007
AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
K062823
Alpha-Omega Services, Inc.
Radiology · 251d
Cleared May 22, 2007
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
K062826
Alpha-Omega Services, Inc.
Radiology · 244d
Cleared May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229
Senorx, Inc.
Radiology · 15d
Cleared Apr 13, 2007
FLEXITRON
K070574
Isodose Control B.V.
Radiology · 44d
Cleared Apr 04, 2007
BIOLUCENT APPLICATOR KIT
K070659
Biolucent, Inc.
Radiology · 26d
Cleared Mar 01, 2007
VARIAN ESOPHAGUS BOUGIE APPLICATOR
K063815
Varian Medical Systems
Radiology · 69d
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 Nov 09, 2006
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
K062241
North American Scientific, Inc.
Radiology · 99d
Cleared Nov 07, 2006
ART SHIELDED BREAST APPLICATOR
K062135
Advanced Radiation Therapy, LLC
Radiology · 104d
Cleared Oct 20, 2006
BIOLUCENT APPLICATOR KIT
K062830
Biolucent, Inc.
Radiology · 30d
Cleared Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
K061354
Nucletron Corporation
Radiology · 94d
Cleared Jul 28, 2006
BIOLUCENT APPLICATOR, MODEL RTA-XX
K061241
Biolucent, Inc.
Radiology · 86d