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
May 28, 2008
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
Nucletron Corporation
Radiology
56d
Cleared
May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
Hologic, Inc.
Radiology
14d
Cleared
May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
Senorx, Inc.
Radiology
16d
Cleared
Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
Senorx, Inc.
Radiology
41d
Cleared
Apr 29, 2008
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
Nucletron Corporation
Radiology
29d
Cleared
Apr 04, 2008
MODIFICATION TO: SAVI APPLICATOR KIT
Cianna Medical, Inc.
Radiology
35d
Cleared
Dec 07, 2007
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
Nucletron Corporation
Radiology
35d
Cleared
Nov 16, 2007
INTERSTITIAL NEEDLES
Varian Medical Systems, Inc.
Radiology
9d
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
Jul 03, 2007
AOS UNIVERSAL CONECTING GUIDE TUBE
Alpha-Omega Services, Inc.
Radiology
286d
Cleared
May 29, 2007
AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
Alpha-Omega Services, Inc.
Radiology
251d
Cleared
May 22, 2007
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
Alpha-Omega Services, Inc.
Radiology
244d
Cleared
May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
Senorx, Inc.
Radiology
15d
Cleared
Apr 13, 2007
FLEXITRON
Isodose Control B.V.
Radiology
44d
Cleared
Apr 04, 2007
BIOLUCENT APPLICATOR KIT
Biolucent, Inc.
Radiology
26d
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
Nov 09, 2006
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
North American Scientific, Inc.
Radiology
99d
Cleared
Nov 07, 2006
ART SHIELDED BREAST APPLICATOR
Advanced Radiation Therapy, LLC
Radiology
104d
Cleared
Oct 20, 2006
BIOLUCENT APPLICATOR KIT
Biolucent, Inc.
Radiology
30d
Cleared
Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
Nucletron Corporation
Radiology
94d
Cleared
Jul 28, 2006
BIOLUCENT APPLICATOR, MODEL RTA-XX
Biolucent, Inc.
Radiology
86d