FDA 510(k) Applications for Medical Device Product Code "JAQ"
(System, Applicator, Radionuclide, Remote-Controlled)

FDA 510(k) Number Applicant Device Name Decision Date
K060299 ADVANCED RADIATION THERAPY, LLC ART BRACHYTHERAPY APPLICATOR 06/06/2006
K062135 ADVANCED RADIATION THERAPY, LLC ART SHIELDED BREAST APPLICATOR 11/07/2006
K062826 ALPHA-OMEGA SERVICES, INC. AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS 05/22/2007
K062823 ALPHA-OMEGA SERVICES, INC. AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES 05/29/2007
K062824 ALPHA-OMEGA SERVICES, INC. AOS UNIVERSAL CONECTING GUIDE TUBE 07/03/2007
K964910 ALPHA-OMEGA SERVICES, INC. AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS 03/10/1997
K031273 AMERTEK MEDICAL, INC. AMERITEK SURE-POINT HDR NEEDLE TEMPLATE 07/15/2003
K042586 BEST MEDICAL INTERNATIONAL, INC. BEST BREAST BRACHYTHERAPY APPLICATOR 11/03/2004
K162499 BEST MEDICAL INTERNATIONAL, INC. Best Instruminal Applicator 04/13/2018
K132097 BEST MEDICAL INTERNATIONAL, INC. BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY 09/30/2013
K062830 BIOLUCENT, INC. BIOLUCENT APPLICATOR KIT 10/20/2006
K070659 BIOLUCENT, INC. BIOLUCENT APPLICATOR KIT 04/04/2007
K061241 BIOLUCENT, INC. BIOLUCENT APPLICATOR, MODEL RTA-XX 07/28/2006
K183332 BRAXX Biotech Co. Ltd ôBRAXXö Esophageal Brachytherapy Applicator 04/16/2019
K180069 C4 Imaging LLC HDR MRI Lumen Marker 04/27/2018
K052595 CAPINTEC, INC. CRC 15ULTRA 11/08/2005
K103215 CIANNA MEDICAL CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT 11/15/2010
K080565 CIANNA MEDICAL, INC. MODIFICATION TO: SAVI APPLICATOR KIT 04/04/2008
K081677 CIANNA MEDICAL, INC. SAVI APPLICATOR KIT 07/22/2008
K101411 CIANNA MEDICAL, INC. SAVI PREPARATION DEVICE 07/12/2010
K990753 COOK, INC. GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER 05/27/1999
K981886 COOK, INC. VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER 11/03/1998
K142986 Eckert & Ziegler BEBIG GmbH SagiNova 04/17/2015
K983436 GAMMAMED USA GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM 10/29/1998
K142719 GC MEDTECH, LLC E-App 05/20/2015
K133922 GC MEDTECH, LLC GENTLECARE AR APPLICATOR 04/18/2014
K201279 Geomed Medizin-Technik GmbH & Co. KG ASSISTO Universal Applicator Clamping Device 07/10/2020
K081179 HOLOGIC, INC. MAMMOSITE CAVITY EVALUATION DEVICE 05/09/2008
K091378 HOLOGIC, INC. MAMMOSITE II RADIATION THERAPY SYSTEM 07/02/2009
K092405 HOLOGIC, INC. MAMMOSITE MULTI LUMEN 08/27/2009
K123442 ICAD, INC. XOFT AXXENT CERVICAL APPLICATORS 02/27/2013
K082530 ISODOSE CONTROL B.V. APPLICATORS FOR AFTERLOADING BRACHYTHERAPY 10/30/2008
K070574 ISODOSE CONTROL B.V. FLEXITRON 04/13/2007
K000081 ISOTOPES AND METALS LTD. MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM 12/19/2000
K160610 KOBOLD, LLC 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 02/13/2017
K142330 KOBOLD, LLC Kobold Ring and Tandem Applicator Set 04/09/2015
K170203 Kobold, LLC System, Applicator, Radionuclide, Remote Controlled 06/01/2017
K063381 MICK RADIO-NUCLEAR INSTRUMENTS, INC. CT COMPATIBLE F/S/D APPLICATORS 12/22/2006
K033828 MICK RADIO-NUCLEAR INSTRUMENTS, INC. CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 02/02/2004
K200221 Mick Radio-Nuclear Instruments, Inc. 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, 02/28/2020
K030110 MICK RADIO-NUCLEAR INSTRUMENTS, INC. CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR 04/03/2003
K122840 MICK RADIO-NUCLEAR INSTRUMENTS, INC. CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 12/14/2012
K150979 Mick Radio-Nuclear Instruments, Inc. CT/MR Compatible M.A.C. Interstitial GYN Template 05/31/2016
K961601 MICK RADIO-NUCLEAR INSTRUMENTS, INC. H.A.M. APPLICATOR 12/23/1996
K993400 MICK RADIO-NUCLEAR INSTRUMENTS, INC. HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES 01/06/2000
K063382 MICK RADIO-NUCLEAR INSTRUMENTS, INC. HDR CT COMPATIBLE SPLIT RING APPLICATOR 12/26/2006
K052351 MICK RADIO-NUCLEAR INSTRUMENTS, INC. HDR IORT SHIELDED APPLICATOR 10/17/2005
K020176 MICK RADIO-NUCLEAR INSTRUMENTS, INC. HDR MIAMI APPLICATOR 04/08/2002
K011657 MICK RADIO-NUCLEAR INSTRUMENTS, INC. HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR 08/27/2001
K051423 MICK RADIO-NUCLEAR INSTRUMENTS, INC. MICK HDR INTERSTITIAL IMPLANT ACCESSORIES 07/01/2005
K230155 Mick Radio-Nuclear Instruments, Inc. Mick Valencia Applicator Set 08/30/2023
K040704 MICK RADIO-NUCLEAR INSTRUMENTS, INC. MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR 06/18/2004
K993472 MICK RADIO-NUCLEAR INSTRUMENTS, INC. SEGMENTED VAGINAL APPLICATOR 01/12/2000
K001544 MICK RADIO-NUCLEAR INSTRUMENTS, INC. VAGINAL APPLICATOR SHIELDED 11/17/2000
K142597 MICK RADIO-NUCLEAR INSTRUMENTS, INC. Vienna System 02/19/2015
K062241 NORTH AMERICAN SCIENTIFIC, INC. ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR 11/09/2006
K112420 NUCLETRON ONCENTRA PROSTATE 4.0 11/18/2011
K111973 NUCLETRON VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET 09/21/2011
K132889 NUCLETRON B.V. FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) 02/26/2014
K151272 NUCLETRON B.V. Henschke Titanium Applicator Set 06/23/2015
K132874 NUCLETRON B.V. LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM 02/21/2014
K140803 NUCLETRON B.V. LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM 06/26/2014
K161688 NUCLETRON BV Advanced Gynecological Applicator 01/27/2017
K201272 Nucletron BV Geneva 07/16/2020
K142439 Nucletron BV Martinez Prostate Template Set 03/10/2015
K990990 NUCLETRON CORP. CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 10/07/1999
K983338 NUCLETRON CORP. FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 04/20/1999
K020015 NUCLETRON CORP. IMPLANT GUIDANCE SYSTEM APPLICATOR SET 03/13/2002
K041715 NUCLETRON CORP. INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 03/24/2005
K091598 NUCLETRON CORP. LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS 06/29/2009
K092804 NUCLETRON CORP. MICROSELECTRON HDR V2, MODEL 105.999 10/08/2009
K021286 NUCLETRON CORP. MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES 05/23/2002
K041933 NUCLETRON CORP. MICROSELECTRON PDR 08/18/2004
K003270 NUCLETRON CORP. PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 12/22/2000
K983337 NUCLETRON CORP. ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 04/02/1999
K010032 NUCLETRON CORP. SEED SELECTRON MODEL V. 1.0 10/17/2001
K983341 NUCLETRON CORP. STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE 04/15/1999
K031158 NUCLETRON CORP. SWIFT 2.0, MODEL 132.001 08/07/2003
K983115 NUCLETRON CORP. TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20 04/02/1999
K022635 NUCLETRON CORPORATION KUSKE BREAST APPLICATOR SET, MODEL 189.006 09/06/2002
K061354 NUCLETRON CORPORATION MICROSELECTRON V3, MODEL 106.990 08/17/2006
K032372 NUCLETRON CORPORATION NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 08/15/2003
K060349 NUCLETRON CORPORATION PROGUIDE NEEDLE SET 03/10/2006
K022739 NUCLETRON CORPORATION REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 10/25/2002
K052228 NUCLETRON CORPORATION SMIT SLEEVE 11/09/2005
K080871 NUCLETRON CORPORATION TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS 04/29/2008
K091154 NUCLETRON CORPORATION UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, 05/18/2009
K073107 NUCLETRON CORPORATION VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 12/07/2007
K080934 NUCLETRON CORPORATION VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET 05/28/2008
K953946 NUCLETRON-OLDELFT CORP. MICROSELECTRON-HDR VERSION 2 08/13/1996
K051753 ONCOLOGY SYSTEMS, INC. ACCU-SOURCE 03/29/2006
K091230 PHOTON TECHNOLOGIES CORPORATION HDR PROSTATE TEMPLATE AND ACCESSORIES 08/12/2009
K041929 PROXIMA THERAPEUTICS, INC. MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY 08/26/2004
K032067 PROXIMA THERAPEUTICS, INC. MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY 02/10/2004
K011690 PROXIMA THERAPEUTICS, INC. MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY 05/06/2002
K030558 PROXIMA THERAPEUTICS, INC. MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY 05/21/2003
K092534 RADIADYNE ALATUS VAGINAL BALLOON PACKING SYSTEM 12/07/2009
K120344 RADIADYNE, LLC (SPECIFICATION DEVELOPER) RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE 05/03/2012
K092323 SENORX, INC. CONTURA CAVITY MAINTENANCE CATHETER 08/19/2009
K082264 SENORX, INC. CONTURA LUMEN MARKER 09/12/2008
K081079 SENORX, INC. CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY 05/02/2008
K080791 SENORX, INC. CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 04/30/2008
K071229 SENORX, INC. SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY 05/18/2007
K052947 SOURCE PRODUCTION & EQUIPMENT CO., INC. SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE 04/19/2006
K123912 SPENCER FILLMORE KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET 05/14/2013
K130757 SPENCER FILLMORE KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET 04/03/2014
K123941 SPENCER FILLMORE KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET 04/30/2013
K060532 STANDARD IMAGING, INC. HDR 1000 PLUS WELL CHAMBER, MODEL 90008 04/11/2006
K001825 STANDARD IMAGING, INC. STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER 08/02/2000
K955844 VARIAN ASSOC., INC. APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER 07/26/1996
K954467 VARIAN ASSOC., INC. CADPLAN BT 03/15/1996
K980601 VARIAN ASSOC., INC. VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER 10/21/1998
K071381 VARIAN MEDICAL SYSTEMS GAMMAMEDPLUS IX SERIES HDR AFTERLOADER 07/18/2007
K063815 VARIAN MEDICAL SYSTEMS VARIAN ESOPHAGUS BOUGIE APPLICATOR 03/01/2007
K033371 VARIAN MEDICAL SYSTEMS VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS 12/24/2003
K023220 VARIAN MEDICAL SYSTEMS VARISOURCE BREAST TEMPLATE SYSTEM 10/25/2002
K221797 Varian Medical Systems Inc. BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device 09/14/2022
K222775 Varian Medical Systems, Inc Aarhus Applicator Set 03/13/2023
K160045 VARIAN MEDICAL SYSTEMS, INC Heyman Packing Applicator Set 11/17/2016
K162533 Varian Medical Systems, Inc Kelowna GYN and Crook Prostate Templates 08/31/2017
K162615 Varian Medical Systems, Inc Mould Applicator Set 03/24/2017
K151657 VARIAN MEDICAL SYSTEMS, INC Shielded Applicator Set, Cervical Stop 08/07/2015
K160516 Varian Medical Systems, Inc 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 08/10/2016
K172611 Varian Medical Systems, Inc 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 03/21/2018
K150839 VARIAN MEDICAL SYSTEMS, INC. 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 07/17/2015
K161540 VARIAN MEDICAL SYSTEMS, INC. Advanced Breast Template System 10/20/2016
K181903 Varian Medical Systems, Inc. BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device 10/03/2018
K191580 Varian Medical Systems, Inc. BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device 07/08/2019
K082653 VARIAN MEDICAL SYSTEMS, INC. CENTERING INTRALUMINAL APPLICATOR 10/10/2008
K113766 VARIAN MEDICAL SYSTEMS, INC. CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN 03/16/2012
K130251 VARIAN MEDICAL SYSTEMS, INC. ESOPHAGUS BOUGIE SET 03/13/2013
K161576 Varian Medical Systems, Inc. Esophagus Bougie Set 10/02/2016
K031524 VARIAN MEDICAL SYSTEMS, INC. GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER 11/26/2003
K120993 VARIAN MEDICAL SYSTEMS, INC. GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER 07/26/2012
K172533 Varian Medical Systems, Inc. GM Implant Tubes, Length Cutting Gauge 10/22/2018
K073133 VARIAN MEDICAL SYSTEMS, INC. INTERSTITIAL NEEDLES 11/16/2007
K160815 VARIAN MEDICAL SYSTEMS, INC. Interstitial Needles 03/10/2017
K151022 VARIAN MEDICAL SYSTEMS, INC. Intraluminal Applicator Set 12/17/2015
K040541 VARIAN MEDICAL SYSTEMS, INC. MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER 03/22/2004
K120341 VARIAN MEDICAL SYSTEMS, INC. PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM 04/27/2012
K141624 VARIAN MEDICAL SYSTEMS, INC. PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 03/10/2015
K141336 VARIAN MEDICAL SYSTEMS, INC. SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS 08/06/2014
K171631 Varian Medical Systems, Inc. Standard Catheter Set 02/09/2018
K162018 Varian Medical Systems, Inc. Surface Applicator Set 02/28/2017
K123815 VARIAN MEDICAL SYSTEMS, INC. SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE 03/11/2013
K120731 VARIAN MEDICAL SYSTEMS, INC. TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY 06/06/2012
K193240 Varian Medical Systems, Inc. Universal Cylinder Applicator Family 08/17/2020
K141490 VARIAN MEDICAL SYSTEMS, INC. UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET 09/26/2014
K172675 Varian Medical Systems, Inc. Varian Cervical Sleeves 05/16/2018
K152018 VARIAN MEDICAL SYSTEMS, INC. Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets 09/11/2015
K980576 VARIAN MEDICAL SYSTEMS, INC. VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER 11/02/1998
K093291 VARIAN MEDICAL SYSTEMS, INC. VARIAN INTERSTITIAL TITANIUM NEEDLES 11/17/2009
K042360 VARIAN MEDICAL SYSTEMS, INC. VARIAN NASOPHARYNX APPLICATOR 02/16/2005
K160021 VARIAN MEDICAL SYSTEMS, INC. Varian Sterilization Boxes 04/13/2016
K061582 VARIAN MEDICAL SYSTEMS, INC. VARISOURCE 200 HDR AFTERLOADER 07/25/2006
K980590 VARIAN MEDICAL SYSTEMS, INC. VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER 10/22/1998
K071467 VARIAN MEDICAL SYSTEMS, INC. VARISOURCE IX HDR AFTERLOADER 07/16/2007
K122236 VARIAN MEDICAL SYSTEMS, INC. VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER 11/16/2012
K092822 VIVARAY, INC. CAPRI APPLICATOR 11/03/2009


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