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 18, 2007
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
Varian Medical Systems
Radiology
62d
Cleared
Jul 16, 2007
VARISOURCE IX HDR AFTERLOADER
Varian Medical Systems, Inc.
Radiology
48d
Cleared
May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
Senorx, Inc.
Radiology
15d
Cleared
Mar 01, 2007
VARIAN ESOPHAGUS BOUGIE APPLICATOR
Varian Medical Systems
Radiology
69d
Cleared
Dec 26, 2006
HDR CT COMPATIBLE SPLIT RING APPLICATOR
Mick Radio-Nuclear Instruments, Inc.
Radiology
48d
Cleared
Dec 22, 2006
CT COMPATIBLE F/S/D APPLICATORS
Mick Radio-Nuclear Instruments, Inc.
Radiology
44d
Cleared
Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
Nucletron Corporation
Radiology
94d
Cleared
Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
Varian Medical Systems, Inc.
Radiology
48d
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
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 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