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
Cleared
Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
Varian Medical Systems, Inc.
Radiology
48d
Cleared
Jun 06, 2006
ART BRACHYTHERAPY APPLICATOR
Advanced Radiation Therapy, LLC
Radiology
120d
Cleared
Apr 19, 2006
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
Source Production & Equipment Co., Inc.
Radiology
181d
Cleared
Apr 11, 2006
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
Standard Imaging, Inc.
Radiology
42d
Cleared
Mar 29, 2006
ACCU-SOURCE
Oncology Systems, Inc.
Radiology
273d
Cleared
Mar 10, 2006
PROGUIDE NEEDLE SET
Nucletron Corporation
Radiology
28d
Cleared
Nov 09, 2005
SMIT SLEEVE
Nucletron Corporation
Radiology
85d
Cleared
Nov 08, 2005
CRC 15ULTRA
Capintec, Inc.
Radiology
48d
Cleared
Oct 17, 2005
HDR IORT SHIELDED APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
49d
Cleared
Jul 01, 2005
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
Mick Radio-Nuclear Instruments, Inc.
Radiology
30d
Cleared
Mar 24, 2005
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
Nucletron Corp.
Radiology
274d
Cleared
Feb 16, 2005
VARIAN NASOPHARYNX APPLICATOR
Varian Medical Systems, Inc.
Radiology
169d
Cleared
Nov 03, 2004
BEST BREAST BRACHYTHERAPY APPLICATOR
Best Medical International, Inc.
Radiology
42d
Cleared
Aug 26, 2004
MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
Proxima Therapeutics, Inc.
Radiology
38d
Cleared
Aug 18, 2004
MICROSELECTRON PDR
Nucletron Corp.
Radiology
30d
Cleared
Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
92d
Cleared
Mar 22, 2004
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
20d
Cleared
Feb 10, 2004
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
Proxima Therapeutics, Inc.
Radiology
222d
Cleared
Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
Mick Radio-Nuclear Instruments, Inc.
Radiology
54d
Cleared
Dec 24, 2003
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
Varian Medical Systems
Radiology
64d
Cleared
Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
Varian Medical Systems, Inc.
Radiology
195d
Cleared
Aug 15, 2003
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
Nucletron Corporation
Radiology
14d
Cleared
Aug 07, 2003
SWIFT 2.0, MODEL 132.001
Nucletron Corp.
Radiology
118d
Cleared
Jul 15, 2003
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
Amertek Medical, Inc.
Radiology
84d