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
Feb 28, 2020
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
Mick Radio-Nuclear Instruments, Inc.
Radiology
30d
Cleared
Jul 08, 2019
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
Varian Medical Systems, Inc.
Radiology
24d
Cleared
Apr 16, 2019
“BRAXX” Esophageal Brachytherapy Applicator
Braxx Biotech Co., Ltd.
Radiology
134d
Cleared
Oct 22, 2018
GM Implant Tubes, Length Cutting Gauge
Varian Medical Systems, Inc.
Radiology
426d
Cleared
Oct 03, 2018
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
Varian Medical Systems, Inc.
Radiology
79d
Cleared
May 16, 2018
Varian Cervical Sleeves
Varian Medical Systems, Inc.
Radiology
253d
Cleared
Apr 27, 2018
HDR MRI Lumen Marker
C4 Imaging, LLC
Radiology
108d
Cleared
Apr 13, 2018
Best Instruminal Applicator
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
Varian Medical Systems, Inc.
Radiology
202d
Cleared
Feb 09, 2018
Standard Catheter Set
Varian Medical Systems, Inc.
Radiology
252d
Cleared
Aug 31, 2017
Kelowna GYN and Crook Prostate Templates
Varian Medical Systems, Inc.
Radiology
356d
Cleared
Jun 01, 2017
System, Applicator, Radionuclide, Remote Controlled
Kobold, LLC
Radiology
129d
Cleared
Mar 24, 2017
Mould Applicator Set
Varian Medical Systems, Inc.
Radiology
186d
Cleared
Mar 10, 2017
Interstitial Needles
Varian Medical Systems, Inc.
Radiology
351d
Cleared
Feb 28, 2017
Surface Applicator Set
Varian Medical Systems, Inc.
Radiology
229d
Cleared
Feb 13, 2017
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
Kobold, LLC
Radiology
347d
Cleared
Jan 27, 2017
Advanced Gynecological Applicator
Nucletron B.V.
Radiology
221d
Cleared
Nov 17, 2016
Heyman Packing Applicator Set
Varian Medical Systems, Inc.
Radiology
314d
Cleared
Oct 20, 2016
Advanced Breast Template System
Varian Medical Systems, Inc.
Radiology
139d
Cleared
Oct 02, 2016
Esophagus Bougie Set
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
Varian Medical Systems, Inc.
Radiology
168d
Cleared
May 31, 2016
CT/MR Compatible M.A.C. Interstitial GYN Template
Mick Radio-Nuclear Instruments, Inc.
Radiology
414d
Cleared
Apr 13, 2016
Varian Sterilization Boxes
Varian Medical Systems, Inc.
Radiology
99d
Cleared
Dec 17, 2015
Intraluminal Applicator Set
Varian Medical Systems, Inc.
Radiology
245d