System, Applicator, Radionuclide, Remote-Controlled
FDA product code JAQ · 190 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.5700
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1978-08-10 – 2026-07-24
JAQ
2026-07-24
JAQ
2026-05-20
MAASTRO Rectal Applicator Set
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JAQ
2025-12-19
Rectal Applicator
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JAQ
2025-11-19
Guided Aarhus Applicator Set
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JAQ
2025-05-09
CT/ MR Tandem and Ovoid Set
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JAQ
2025-04-25
Intracavitary/Interstitial System
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JAQ
2025-03-03
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
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JAQ
2025-01-10
Mould Probe MR Safe
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JAQ
2024-11-26
Intraluminal Applicator Set
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JAQ
2024-11-19
“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
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JAQ
2024-11-07
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve
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JAQ
2024-10-29
Catheter Surface Flap Applicator Set (GM11011830)
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JAQ
2024-08-30
Heyman Packing Applicator Set (GM11004580)
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JAQ
2024-07-10
AOS Interstitial Templates, Needles, and Accessories
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JAQ
2024-07-02
AOS Marker Seeds (SMG0242-025)
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JAQ
2024-05-09
Flexible Fixation Device for Gynecological Applicators (GM11001960)
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JAQ
2024-04-09
Universal Endometrial Applicator Set (GM11009840)
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JAQ
2024-02-01
Kelowna GYN and Crook Prostate Templates
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JAQ
2023-08-30
Mick Valencia Applicator Set
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JAQ
2023-03-13
Aarhus Applicator Set
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JAQ
2022-09-14
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
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JAQ
2020-08-17
Universal Cylinder Applicator Family
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JAQ
2020-07-16
Geneva
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JAQ
2020-07-10
ASSISTO Universal Applicator Clamping Device
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JAQ
2020-02-28
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
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JAQ
2019-07-08
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
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JAQ
2019-04-16
“BRAXX” Esophageal Brachytherapy Applicator
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JAQ
2018-10-22
GM Implant Tubes, Length Cutting Gauge
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JAQ
2018-10-03
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
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JAQ
2018-05-16
Varian Cervical Sleeves
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JAQ
2018-04-27
HDR MRI Lumen Marker
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JAQ
2018-04-13
Best Instruminal Applicator
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JAQ
2018-03-21
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
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JAQ
2018-02-09
Standard Catheter Set
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JAQ
2017-08-31
Kelowna GYN and Crook Prostate Templates
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JAQ
2017-06-01
System, Applicator, Radionuclide, Remote Controlled
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JAQ
2017-03-24
Mould Applicator Set
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JAQ
2017-03-10
Interstitial Needles
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JAQ
2017-02-28
Surface Applicator Set
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JAQ
2017-02-13
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
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JAQ
2017-01-27
Advanced Gynecological Applicator
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JAQ
2016-11-17
Heyman Packing Applicator Set
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JAQ
2016-10-20
Advanced Breast Template System
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JAQ
2016-10-02
Esophagus Bougie Set
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JAQ
2016-08-10
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
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JAQ
2016-05-31
CT/MR Compatible M.A.C. Interstitial GYN Template
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JAQ
2016-04-13
Varian Sterilization Boxes
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JAQ
2013-09-30
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
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JAQ
2013-05-14
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
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JAQ
2013-04-30
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET
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JAQ
2013-03-13
ESOPHAGUS BOUGIE SET
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JAQ
2013-03-11
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
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JAQ
2013-02-27
XOFT AXXENT CERVICAL APPLICATORS
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JAQ
2012-12-14
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
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JAQ
2012-11-16
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
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JAQ
2012-07-26
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
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JAQ
2012-06-06
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
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JAQ
2012-05-03
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
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JAQ
2012-04-27
PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
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JAQ
2012-03-16
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
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JAQ
2011-11-18
ONCENTRA PROSTATE 4.0
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JAQ
2011-09-21
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
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JAQ
2010-11-15
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
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JAQ
2010-07-12
SAVI PREPARATION DEVICE
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JAQ
2009-12-07
ALATUS VAGINAL BALLOON PACKING SYSTEM
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JAQ
2009-11-17
VARIAN INTERSTITIAL TITANIUM NEEDLES
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JAQ
2009-11-03
CAPRI APPLICATOR
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JAQ
2009-10-08
MICROSELECTRON HDR V2, MODEL 105.999
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JAQ
2009-08-27
MAMMOSITE MULTI LUMEN
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JAQ
2009-08-19
CONTURA CAVITY MAINTENANCE CATHETER
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JAQ
2009-08-12
HDR PROSTATE TEMPLATE AND ACCESSORIES
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JAQ
2009-07-02
MAMMOSITE II RADIATION THERAPY SYSTEM
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JAQ
2009-06-29
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS
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JAQ
2009-05-18
UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
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JAQ
2008-10-30
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
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JAQ
2008-10-10
CENTERING INTRALUMINAL APPLICATOR
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JAQ
2008-09-12
CONTURA LUMEN MARKER
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JAQ
2008-07-22
SAVI APPLICATOR KIT
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JAQ
2008-05-28
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
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JAQ
2008-05-09
MAMMOSITE CAVITY EVALUATION DEVICE
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JAQ
2008-05-02
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
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JAQ
2008-04-30
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
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JAQ
2008-04-29
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
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JAQ
2008-04-04
MODIFICATION TO: SAVI APPLICATOR KIT
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JAQ
2007-12-07
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
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JAQ
2007-11-16
INTERSTITIAL NEEDLES
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JAQ
2007-07-18
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
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JAQ
2007-07-16
VARISOURCE IX HDR AFTERLOADER
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JAQ
2007-07-03
AOS UNIVERSAL CONECTING GUIDE TUBE
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JAQ
2007-05-29
AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
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JAQ
2007-05-22
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
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JAQ
2007-05-18
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
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JAQ
2007-04-13
FLEXITRON
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JAQ
2007-04-04
BIOLUCENT APPLICATOR KIT
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JAQ
2007-03-01
VARIAN ESOPHAGUS BOUGIE APPLICATOR
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JAQ
2006-12-26
HDR CT COMPATIBLE SPLIT RING APPLICATOR
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JAQ
2006-12-22
CT COMPATIBLE F/S/D APPLICATORS
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JAQ
2006-11-09
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
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JAQ
2006-11-07
ART SHIELDED BREAST APPLICATOR
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JAQ
2006-10-20
BIOLUCENT APPLICATOR KIT
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