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
121–144 of 208
Cleared Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
K061582
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jun 06, 2006
ART BRACHYTHERAPY APPLICATOR
K060299
Advanced Radiation Therapy, LLC
Radiology · 120d
Cleared Apr 19, 2006
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
K052947
Source Production & Equipment Co., Inc.
Radiology · 181d
Cleared Apr 11, 2006
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
K060532
Standard Imaging, Inc.
Radiology · 42d
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 Nov 08, 2005
CRC 15ULTRA
K052595
Capintec, 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 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 10, 2004
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
K032067
Proxima Therapeutics, Inc.
Radiology · 222d
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
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158
Nucletron Corp.
Radiology · 118d
Cleared Jul 15, 2003
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
K031273
Amertek Medical, Inc.
Radiology · 84d