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
Sep 11, 2015
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
Varian Medical Systems, Inc.
Radiology
52d
Cleared
Aug 07, 2015
Shielded Applicator Set, Cervical Stop
Varian Medical Systems, Inc.
Radiology
49d
Cleared
Jul 17, 2015
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
Varian Medical Systems, Inc.
Radiology
109d
Cleared
Jun 23, 2015
Henschke Titanium Applicator Set
Nucletron B.V.
Radiology
41d
Cleared
May 20, 2015
E-App
Gc Medtech, LLC
Radiology
239d
Cleared
Apr 17, 2015
SagiNova
Eckert & Ziegler Bebig GmbH
Radiology
183d
Cleared
Apr 09, 2015
Kobold Ring and Tandem Applicator Set
Kobold, LLC
Radiology
232d
Cleared
Mar 10, 2015
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
Varian Medical Systems, Inc.
Radiology
266d
Cleared
Mar 10, 2015
Martinez Prostate Template Set
Nucletron B.V.
Radiology
193d
Cleared
Feb 19, 2015
Vienna System
Mick Radio-Nuclear Instruments, Inc.
Radiology
157d
Cleared
Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
Varian Medical Systems, Inc.
Radiology
113d
Cleared
Aug 06, 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
Varian Medical Systems, Inc.
Radiology
77d
Cleared
Jun 26, 2014
LUNERAY
Nucletron B.V.
Radiology
87d
Cleared
Apr 18, 2014
GENTLECARE AR APPLICATOR
Gc Medtech, LLC
Radiology
116d
Cleared
Apr 03, 2014
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET
Spencer Fillmore
Radiology
379d
Cleared
Feb 26, 2014
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
Nucletron B.V.
Radiology
163d
Cleared
Feb 21, 2014
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
Nucletron B.V.
Radiology
161d
Cleared
Sep 30, 2013
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
Best Medical International, Inc.
Radiology
84d
Cleared
May 14, 2013
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
Spencer Fillmore
Radiology
146d
Cleared
Apr 30, 2013
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
Spencer Fillmore
Radiology
131d
Cleared
Mar 13, 2013
ESOPHAGUS BOUGIE SET
Varian Medical Systems, Inc.
Radiology
40d
Cleared
Mar 11, 2013
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
Varian Medical Systems, Inc.
Radiology
89d
Cleared
Feb 27, 2013
XOFT AXXENT CERVICAL APPLICATORS
Icad, Inc.
Radiology
111d
Cleared
Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
Mick Radio-Nuclear Instruments, Inc.
Radiology
88d