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 Varian Assoc., Inc..

208
Total
208
Cleared
136d
Avg days
1978
Since
208 devices
25–48 of 208
Cleared Jul 08, 2019
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
K191580
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Apr 16, 2019
“BRAXX” Esophageal Brachytherapy Applicator
K183332
Braxx Biotech Co., Ltd.
Radiology · 134d
Cleared Oct 22, 2018
GM Implant Tubes, Length Cutting Gauge
K172533
Varian Medical Systems, Inc.
Radiology · 426d
Cleared Oct 03, 2018
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
K181903
Varian Medical Systems, Inc.
Radiology · 79d
Cleared May 16, 2018
Varian Cervical Sleeves
K172675
Varian Medical Systems, Inc.
Radiology · 253d
Cleared Apr 27, 2018
HDR MRI Lumen Marker
K180069
C4 Imaging, LLC
Radiology · 108d
Cleared Apr 13, 2018
Best Instruminal Applicator
K162499
Best Medical International, Inc.
Radiology · 583d
Cleared Mar 21, 2018
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
K172611
Varian Medical Systems, Inc.
Radiology · 202d
Cleared Feb 09, 2018
Standard Catheter Set
K171631
Varian Medical Systems, Inc.
Radiology · 252d
Cleared Aug 31, 2017
Kelowna GYN and Crook Prostate Templates
K162533
Varian Medical Systems, Inc.
Radiology · 356d
Cleared Mar 24, 2017
Mould Applicator Set
K162615
Varian Medical Systems, Inc.
Radiology · 186d
Cleared Mar 10, 2017
Interstitial Needles
K160815
Varian Medical Systems, Inc.
Radiology · 351d
Cleared Feb 28, 2017
Surface Applicator Set
K162018
Varian Medical Systems, Inc.
Radiology · 229d
Cleared Nov 17, 2016
Heyman Packing Applicator Set
K160045
Varian Medical Systems, Inc.
Radiology · 314d
Cleared Oct 20, 2016
Advanced Breast Template System
K161540
Varian Medical Systems, Inc.
Radiology · 139d
Cleared Oct 02, 2016
Esophagus Bougie Set
K161576
Varian Medical Systems, Inc.
Radiology · 117d
Cleared Aug 10, 2016
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
K160516
Varian Medical Systems, Inc.
Radiology · 168d
Cleared May 31, 2016
CT/MR Compatible M.A.C. Interstitial GYN Template
K150979
Mick Radio-Nuclear Instruments, Inc.
Radiology · 414d
Cleared Apr 13, 2016
Varian Sterilization Boxes
K160021
Varian Medical Systems, Inc.
Radiology · 99d
Cleared Dec 17, 2015
Intraluminal Applicator Set
K151022
Varian Medical Systems, Inc.
Radiology · 245d
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 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