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
49–72 of 208
Cleared Sep 11, 2015
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
K152018
Varian Medical Systems, Inc.
Radiology · 52d
Cleared Aug 07, 2015
Shielded Applicator Set, Cervical Stop
K151657
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
K150839
Varian Medical Systems, Inc.
Radiology · 109d
Cleared Jun 23, 2015
Henschke Titanium Applicator Set
K151272
Nucletron B.V.
Radiology · 41d
Cleared May 20, 2015
E-App
K142719
Gc Medtech, LLC
Radiology · 239d
Cleared Apr 17, 2015
SagiNova
K142986
Eckert & Ziegler Bebig GmbH
Radiology · 183d
Cleared Apr 09, 2015
Kobold Ring and Tandem Applicator Set
K142330
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
K141624
Varian Medical Systems, Inc.
Radiology · 266d
Cleared Mar 10, 2015
Martinez Prostate Template Set
K142439
Nucletron B.V.
Radiology · 193d
Cleared Feb 19, 2015
Vienna System
K142597
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Aug 06, 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
K141336
Varian Medical Systems, Inc.
Radiology · 77d
Cleared Jun 26, 2014
LUNERAY
K140803
Nucletron B.V.
Radiology · 87d
Cleared Apr 18, 2014
GENTLECARE AR APPLICATOR
K133922
Gc Medtech, LLC
Radiology · 116d
Cleared Apr 03, 2014
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET
K130757
Spencer Fillmore
Radiology · 379d
Cleared Feb 26, 2014
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
K132889
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
K132874
Nucletron B.V.
Radiology · 161d
Cleared Sep 30, 2013
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
K132097
Best Medical International, Inc.
Radiology · 84d
Cleared May 14, 2013
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
K123912
Spencer Fillmore
Radiology · 146d
Cleared Apr 30, 2013
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
K123941
Spencer Fillmore
Radiology · 131d
Cleared Mar 13, 2013
ESOPHAGUS BOUGIE SET
K130251
Varian Medical Systems, Inc.
Radiology · 40d
Cleared Mar 11, 2013
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
K123815
Varian Medical Systems, Inc.
Radiology · 89d
Cleared Feb 27, 2013
XOFT AXXENT CERVICAL APPLICATORS
K123442
Icad, Inc.
Radiology · 111d
Cleared Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
K122840
Mick Radio-Nuclear Instruments, Inc.
Radiology · 88d