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 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 May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229
Senorx, Inc.
Radiology · 15d
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 Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
K061354
Nucletron Corporation
Radiology · 94d
Cleared Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
K061582
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Mar 29, 2006
ACCU-SOURCE
K051753
Oncology Systems, Inc.
Radiology · 273d
Cleared Mar 10, 2006
PROGUIDE NEEDLE SET
K060349
Nucletron Corporation
Radiology · 28d
Cleared Nov 09, 2005
SMIT SLEEVE
K052228
Nucletron Corporation
Radiology · 85d
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 Mar 24, 2005
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
K041715
Nucletron Corp.
Radiology · 274d
Cleared Feb 16, 2005
VARIAN NASOPHARYNX APPLICATOR
K042360
Varian Medical Systems, Inc.
Radiology · 169d
Cleared Nov 03, 2004
BEST BREAST BRACHYTHERAPY APPLICATOR
K042586
Best Medical International, Inc.
Radiology · 42d
Cleared Aug 26, 2004
MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
K041929
Proxima Therapeutics, Inc.
Radiology · 38d
Cleared Aug 18, 2004
MICROSELECTRON PDR
K041933
Nucletron Corp.
Radiology · 30d
Cleared Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
K040704
Mick Radio-Nuclear Instruments, Inc.
Radiology · 92d
Cleared Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
K040541
Varian Medical Systems, Inc.
Radiology · 20d
Cleared Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
K033828
Mick Radio-Nuclear Instruments, Inc.
Radiology · 54d
Cleared Dec 24, 2003
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
K033371
Varian Medical Systems
Radiology · 64d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524
Varian Medical Systems, Inc.
Radiology · 195d
Cleared Aug 15, 2003
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
K032372
Nucletron Corporation
Radiology · 14d