JAQ · System, Applicator, Radionuclide, Remote-Controlled
Radiology · 21 CFR 892.5700 · Class 2
Overview
| Product Code | JAQ |
|---|---|
| Device Name | System, Applicator, Radionuclide, Remote-Controlled |
| Regulation | 21 CFR 892.5700 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
Classification Rationale
Class II.
Cleared Devices (206)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251037 | Rectal Applicator | Nucletron B.V. | Dec 19, 2025 | SESE |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | Nov 19, 2025 | SESE |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | May 9, 2025 | SESE |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | Apr 25, 2025 | SESE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | Mar 3, 2025 | SESE |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | Jan 10, 2025 | SESE |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | Nov 26, 2024 | SESE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | Nov 19, 2024 | SESE |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | Nov 7, 2024 | SESE |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | Oct 29, 2024 | SESE |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | Aug 30, 2024 | SESE |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | Jul 10, 2024 | SESE |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | Jul 2, 2024 | SESE |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | Varian Medical Systems, Inc. | May 9, 2024 | SESE |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | Apr 9, 2024 | SESE |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | Feb 1, 2024 | SESE |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | Aug 30, 2023 | SESE |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | Mar 13, 2023 | SESE |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | Varian Medical Systems, Inc. | Sep 14, 2022 | SESE |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | Aug 17, 2020 | SESE |
| K201272 | Geneva | Nucletron B.V. | Jul 16, 2020 | SESE |
| K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | Jul 10, 2020 | SESE |
| K200221 | 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. | Feb 28, 2020 | SESE |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | Jul 8, 2019 | SESE |
| K183332 | BRAXX Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | Apr 16, 2019 | SESE |
| K172533 | GM Implant Tubes, Length Cutting Gauge | Varian Medical Systems, Inc. | Oct 22, 2018 | SESE |
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device | Varian Medical Systems, Inc. | Oct 3, 2018 | SESE |
| K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | May 16, 2018 | SESE |
| K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | Apr 27, 2018 | SESE |
| K162499 | Best Instruminal Applicator | Best Medical International, Inc. | Apr 13, 2018 | SESE |
| K172611 | 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. | Mar 21, 2018 | SESE |
| K171631 | Standard Catheter Set | Varian Medical Systems, Inc. | Feb 9, 2018 | SESE |
| K162533 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | Aug 31, 2017 | SESE |
| K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | Jun 1, 2017 | SESE |
| K162615 | Mould Applicator Set | Varian Medical Systems, Inc. | Mar 24, 2017 | SESE |
| K160815 | Interstitial Needles | Varian Medical Systems, Inc. | Mar 10, 2017 | SESE |
| K162018 | Surface Applicator Set | Varian Medical Systems, Inc. | Feb 28, 2017 | SESE |
| K160610 | 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 | Feb 13, 2017 | SESE |
| K161688 | Advanced Gynecological Applicator | Nucletron B.V. | Jan 27, 2017 | SESE |
| K160045 | Heyman Packing Applicator Set | Varian Medical Systems, Inc. | Nov 17, 2016 | SESE |
| K161540 | Advanced Breast Template System | Varian Medical Systems, Inc. | Oct 20, 2016 | SESE |
| K161576 | Esophagus Bougie Set | Varian Medical Systems, Inc. | Oct 2, 2016 | SESE |
| K160516 | 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. | Aug 10, 2016 | SESE |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | Mick Radio-Nuclear Instruments, Inc. | May 31, 2016 | SESE |
| K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | Apr 13, 2016 | SESE |
| K151022 | Intraluminal Applicator Set | Varian Medical Systems, Inc. | Dec 17, 2015 | SESE |
| K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets | Varian Medical Systems, Inc. | Sep 11, 2015 | SESE |
| K151657 | Shielded Applicator Set, Cervical Stop | Varian Medical Systems, Inc. | Aug 7, 2015 | SESE |
| K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 | Varian Medical Systems, Inc. | Jul 17, 2015 | SESE |
| K151272 | Henschke Titanium Applicator Set | Nucletron B.V. | Jun 23, 2015 | SESE |
| K142719 | E-App | Gc Medtech, LLC | May 20, 2015 | SESE |
| K142986 | SagiNova | Eckert & Ziegler Bebig GmbH | Apr 17, 2015 | SESE |
| K142330 | Kobold Ring and Tandem Applicator Set | Kobold, LLC | Apr 9, 2015 | SESE |
| K142439 | Martinez Prostate Template Set | Nucletron B.V. | Mar 10, 2015 | SESE |
| K141624 | PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 | Varian Medical Systems, Inc. | Mar 10, 2015 | SESE |
| K142597 | Vienna System | Mick Radio-Nuclear Instruments, Inc. | Feb 19, 2015 | SESE |
| K141490 | UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET | Varian Medical Systems, Inc. | Sep 26, 2014 | SESE |
| K141336 | SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS | Varian Medical Systems, Inc. | Aug 6, 2014 | SESE |
| K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM | Nucletron B.V. | Jun 26, 2014 | SESE |
| K133922 | GENTLECARE AR APPLICATOR | Gc Medtech, LLC | Apr 18, 2014 | SESE |
| K130757 | KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET | Spencer Fillmore | Apr 3, 2014 | SESE |
| K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) | Nucletron B.V. | Feb 26, 2014 | SESE |
| K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM | Nucletron B.V. | Feb 21, 2014 | SESE |
| K132097 | BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY | Best Medical International, Inc. | Sep 30, 2013 | SESE |
| K123912 | KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET | Spencer Fillmore | May 14, 2013 | SESE |
| K123941 | KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET | Spencer Fillmore | Apr 30, 2013 | SESE |
| K130251 | ESOPHAGUS BOUGIE SET | Varian Medical Systems, Inc. | Mar 13, 2013 | SESE |
| K123815 | SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE | Varian Medical Systems, Inc. | Mar 11, 2013 | SESE |
| K123442 | XOFT AXXENT CERVICAL APPLICATORS | Icad, Inc. | Feb 27, 2013 | SESE |
| K122840 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 | Mick Radio-Nuclear Instruments, Inc. | Dec 14, 2012 | SESE |
| K122236 | VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER | Varian Medical Systems, Inc. | Nov 16, 2012 | SESE |
| K120993 | GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER | Varian Medical Systems, Inc. | Jul 26, 2012 | SESE |
| K120731 | TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY | Varian Medical Systems, Inc. | Jun 6, 2012 | SESE |
| K120344 | RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE | Radiadyne, LLC (Specification Developer) | May 3, 2012 | SESE |
| K120341 | PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM | Varian Medical Systems, Inc. | Apr 27, 2012 | SESE |
| K113766 | CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN | Varian Medical Systems, Inc. | Mar 16, 2012 | SESE |
| K112420 | ONCENTRA PROSTATE 4.0 | Nucletron | Nov 18, 2011 | SESE |
| K111973 | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET | Nucletron | Sep 21, 2011 | SESE |
| K103215 | CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT | Cianna Medical | Nov 15, 2010 | SESE |
| K101411 | SAVI PREPARATION DEVICE | Cianna Medical, Inc. | Jul 12, 2010 | SESE |
| K092534 | ALATUS VAGINAL BALLOON PACKING SYSTEM | Radiadyne | Dec 7, 2009 | SESE |
| K093291 | VARIAN INTERSTITIAL TITANIUM NEEDLES | Varian Medical Systems, Inc. | Nov 17, 2009 | SESE |
| K092822 | CAPRI APPLICATOR | Vivaray, Inc. | Nov 3, 2009 | SESE |
| K092804 | MICROSELECTRON HDR V2, MODEL 105.999 | Nucletron Corp. | Oct 8, 2009 | SESE |
| K092405 | MAMMOSITE MULTI LUMEN | Hologic, Inc. | Aug 27, 2009 | SESU |
| K092323 | CONTURA CAVITY MAINTENANCE CATHETER | Senorx, Inc. | Aug 19, 2009 | SESE |
| K091230 | HDR PROSTATE TEMPLATE AND ACCESSORIES | Photon Technologies Corporation | Aug 12, 2009 | SESE |
| K091378 | MAMMOSITE II RADIATION THERAPY SYSTEM | Hologic, Inc. | Jul 2, 2009 | SESU |
| K091598 | LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS | Nucletron Corp. | Jun 29, 2009 | SESE |
| K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, | Nucletron Corporation | May 18, 2009 | SESE |
| K082530 | APPLICATORS FOR AFTERLOADING BRACHYTHERAPY | Isodose Control B.V. | Oct 30, 2008 | SESE |
| K082653 | CENTERING INTRALUMINAL APPLICATOR | Varian Medical Systems, Inc. | Oct 10, 2008 | SESE |
| K082264 | CONTURA LUMEN MARKER | Senorx, Inc. | Sep 12, 2008 | SESU |
| K081677 | SAVI APPLICATOR KIT | Cianna Medical, Inc. | Jul 22, 2008 | SESU |
| K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET | Nucletron Corporation | May 28, 2008 | SESE |
| K081179 | MAMMOSITE CAVITY EVALUATION DEVICE | Hologic, Inc. | May 9, 2008 | SESE |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | Senorx, Inc. | May 2, 2008 | SESU |
| K080791 | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 | Senorx, Inc. | Apr 30, 2008 | SESU |
| K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS | Nucletron Corporation | Apr 29, 2008 | SESE |
| K080565 | MODIFICATION TO: SAVI APPLICATOR KIT | Cianna Medical, Inc. | Apr 4, 2008 | SESU |
| K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 | Nucletron Corporation | Dec 7, 2007 | SESE |
| K073133 | INTERSTITIAL NEEDLES | Varian Medical Systems, Inc. | Nov 16, 2007 | SESE |
| K071381 | GAMMAMEDPLUS IX SERIES HDR AFTERLOADER | Varian Medical Systems | Jul 18, 2007 | SESE |
| K071467 | VARISOURCE IX HDR AFTERLOADER | Varian Medical Systems, Inc. | Jul 16, 2007 | SESE |
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | Alpha-Omega Services, Inc. | Jul 3, 2007 | SESE |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | Alpha-Omega Services, Inc. | May 29, 2007 | SESE |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | Alpha-Omega Services, Inc. | May 22, 2007 | SESE |
| K071229 | SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY | Senorx, Inc. | May 18, 2007 | SESU |
| K070574 | FLEXITRON | Isodose Control B.V. | Apr 13, 2007 | SESE |
| K070659 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | Apr 4, 2007 | SESU |
| K063815 | VARIAN ESOPHAGUS BOUGIE APPLICATOR | Varian Medical Systems | Mar 1, 2007 | SESE |
| K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Dec 26, 2006 | SESE |
| K063381 | CT COMPATIBLE F/S/D APPLICATORS | Mick Radio-Nuclear Instruments, Inc. | Dec 22, 2006 | SESE |
| K062241 | ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR | North American Scientific, Inc. | Nov 9, 2006 | SESU |
| K062135 | ART SHIELDED BREAST APPLICATOR | Advanced Radiation Therapy, LLC | Nov 7, 2006 | SESE |
| K062830 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | Oct 20, 2006 | SESE |
| K061354 | MICROSELECTRON V3, MODEL 106.990 | Nucletron Corporation | Aug 17, 2006 | SESE |
| K061241 | BIOLUCENT APPLICATOR, MODEL RTA-XX | Biolucent, Inc. | Jul 28, 2006 | SESE |
| K061582 | VARISOURCE 200 HDR AFTERLOADER | Varian Medical Systems, Inc. | Jul 25, 2006 | SESE |
| K060299 | ART BRACHYTHERAPY APPLICATOR | Advanced Radiation Therapy, LLC | Jun 6, 2006 | SESE |
| K052947 | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE | Source Production & Equipment Co., Inc. | Apr 19, 2006 | SESE |
| K060532 | HDR 1000 PLUS WELL CHAMBER, MODEL 90008 | Standard Imaging, Inc. | Apr 11, 2006 | SESE |
| K051753 | ACCU-SOURCE | Oncology Systems, Inc. | Mar 29, 2006 | SESE |
| K060349 | PROGUIDE NEEDLE SET | Nucletron Corporation | Mar 10, 2006 | SESE |
| K052228 | SMIT SLEEVE | Nucletron Corporation | Nov 9, 2005 | SESE |
| K052595 | CRC 15ULTRA | Capintec, Inc. | Nov 8, 2005 | SESE |
| K052351 | HDR IORT SHIELDED APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Oct 17, 2005 | SESE |
| K051423 | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES | Mick Radio-Nuclear Instruments, Inc. | Jul 1, 2005 | SESE |
| K041715 | INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 | Nucletron Corp. | Mar 24, 2005 | SESE |
| K042360 | VARIAN NASOPHARYNX APPLICATOR | Varian Medical Systems, Inc. | Feb 16, 2005 | SESE |
| K042586 | BEST BREAST BRACHYTHERAPY APPLICATOR | Best Medical International, Inc. | Nov 3, 2004 | SESE |
| K041929 | MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | Aug 26, 2004 | SESE |
| K041933 | MICROSELECTRON PDR | Nucletron Corp. | Aug 18, 2004 | SESE |
| K040704 | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Jun 18, 2004 | SESE |
| K040541 | MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER | Varian Medical Systems, Inc. | Mar 22, 2004 | SESE |
| K032067 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | Feb 10, 2004 | SESE |
| K033828 | CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 | Mick Radio-Nuclear Instruments, Inc. | Feb 2, 2004 | SESE |
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS | Varian Medical Systems | Dec 24, 2003 | SESE |
| K031524 | GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER | Varian Medical Systems, Inc. | Nov 26, 2003 | SESE |
| K032372 | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 | Nucletron Corporation | Aug 15, 2003 | SESE |
| K031158 | SWIFT 2.0, MODEL 132.001 | Nucletron Corp. | Aug 7, 2003 | SESE |
| K031273 | AMERITEK SURE-POINT HDR NEEDLE TEMPLATE | Amertek Medical, Inc. | Jul 15, 2003 | SESE |
| K030558 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | May 21, 2003 | SESE |
| K030110 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | Mick Radio-Nuclear Instruments, Inc. | Apr 3, 2003 | SESE |
| K023220 | VARISOURCE BREAST TEMPLATE SYSTEM | Varian Medical Systems | Oct 25, 2002 | SESE |
| K022739 | REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 | Nucletron Corporation | Oct 25, 2002 | SESE |
| K022635 | KUSKE BREAST APPLICATOR SET, MODEL 189.006 | Nucletron Corporation | Sep 6, 2002 | SESE |
| K021286 | MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES | Nucletron Corp. | May 23, 2002 | SESE |
| K011690 | MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY | Proxima Therapeutics, Inc. | May 6, 2002 | SESU |
| K020176 | HDR MIAMI APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Apr 8, 2002 | SESE |
| K020015 | IMPLANT GUIDANCE SYSTEM APPLICATOR SET | Nucletron Corp. | Mar 13, 2002 | SESE |
| K010032 | SEED SELECTRON MODEL V. 1.0 | Nucletron Corp. | Oct 17, 2001 | SESE |
| K011657 | HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | Mick Radio-Nuclear Instruments, Inc. | Aug 27, 2001 | SESE |
| K003270 | PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 | Nucletron Corp. | Dec 22, 2000 | SESE |
| K000081 | MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM | Isotopes and Metals , Ltd. | Dec 19, 2000 | SESE |
| K001544 | VAGINAL APPLICATOR SHIELDED | Mick Radio-Nuclear Instruments, Inc. | Nov 17, 2000 | SESE |
| K001825 | STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER | Standard Imaging, Inc. | Aug 2, 2000 | SESE |
| K993472 | SEGMENTED VAGINAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Jan 12, 2000 | SESE |
| K993400 | HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES | Mick Radio-Nuclear Instruments, Inc. | Jan 6, 2000 | SESE |
| K990990 | CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 | Nucletron Corp. | Oct 7, 1999 | SESE |
| K990753 | GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER | Cook, Inc. | May 27, 1999 | SESE |
| K983338 | FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 | Nucletron Corp. | Apr 20, 1999 | SESE |
| K983341 | STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE | Nucletron Corp. | Apr 15, 1999 | SESE |
| K983337 | ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 | Nucletron Corp. | Apr 2, 1999 | SESE |
| K983115 | TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20 | Nucletron Corp. | Apr 2, 1999 | SESE |
| K981886 | VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER | Cook, Inc. | Nov 3, 1998 | SESE |
| K980576 | VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Varian Medical Systems, Inc. | Nov 2, 1998 | SESE |
| K983436 | GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM | Gammamed USA | Oct 29, 1998 | SESE |
| K980590 | VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Varian Medical Systems, Inc. | Oct 22, 1998 | SESE |
| K980601 | VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER | Varian Assoc., Inc. | Oct 21, 1998 | SESE |
| K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS | Alpha-Omega Services, Inc. | Mar 10, 1997 | SESE |
| K961601 | H.A.M. APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Dec 23, 1996 | SESE |
| K953946 | MICROSELECTRON-HDR VERSION 2 | Nucletron-Oldelft Corp. | Aug 13, 1996 | SESE |
| K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | Varian Assoc., Inc. | Jul 26, 1996 | SESE |
| K954467 | CADPLAN BT | Varian Assoc., Inc. | Mar 15, 1996 | SESE |
| K952913 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER | Varian Assoc., Inc. | Nov 22, 1995 | SESE |
| K945383 | HIGH DOSE RATE AFTERLOADER | Varian Assoc., Inc. | Feb 15, 1995 | SESE |
| K943109 | REMOTE CONTROL RADIOISOTOPE APPLICATOR | Inter-Pal GmbH | Feb 9, 1995 | SESE |
| K925956 | MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT | Nucletron-Oldelft Corp. | Nov 19, 1993 | SESE |
| K923738 | HIGH DOSE RATE REMOTE AFTERLOADING CATHETER | Cook, Inc. | Apr 13, 1993 | SESE |
| K922564 | 6 FRENCH CATHETER | S. and H. Engineering, Inc. | Dec 17, 1992 | SESE |
| K901615 | PULMOCATH INTRABRONCHIAL CATHETER | Omnitron Intl., Inc. | Nov 27, 1992 | SESE |
| K915622 | PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM | Nucletron-Oldelft Corp. | Sep 25, 1992 | SESE |
| K922554 | STANDARD IMAGING HDR 1000 ION CHAMBER | Standard Imaging, Inc. | Aug 24, 1992 | SESE |
| K920431 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE | Omnitron Intl., Inc. | May 29, 1992 | SESE |
| K915367 | HDRS-1 SYSTEM | Precision Radiation Measurement, Inc. | Apr 6, 1992 | SESE |
| K913908 | OMNITRON GYN APPLICATOR SYSTEM | Omnitron Intl., Inc. | Mar 6, 1992 | SESE |
| K914578 | RTS TECHNOLOGY MODELS 721,722,723,724 | Rts Technology, Inc. | Feb 28, 1992 | SESE |
| K912555 | GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER | Rts Technology, Inc. | Aug 2, 1991 | SESE |
| K902533 | PULSED SELECTRON | Nucletron-Oldelft Corp. | Oct 12, 1990 | SESE |
| K901589 | RTS TECHNOLOGY IRIDIUM 192 SOURCES | Rts Technology, Inc. | Aug 17, 1990 | SESE |
| K890294 | INTER-PAL C-19 AND INTER-PAL C-38 | Enrad Corp. | Feb 1, 1990 | SESE |
| K894381 | GAMMAMED IRIDIUM-192 SOURCE | Mick Radio-Nuclear Instruments, Inc. | Nov 21, 1989 | SESE |
| K890799 | CURIETRON 192 HIGH DOSE RATE | Cis-Us, Inc. | Oct 27, 1989 | SESE |
| K891131 | GAMMAMED 12I | Mick Radio-Nuclear Instruments, Inc. | Aug 7, 1989 | SESE |
| K881323 | CURIETRON 192 LOW DOSE RATE | Compagnie Oris Industrie, S.A. | Jan 17, 1989 | SESE |
| K881665 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR | Omnitron Intl., Inc. | Aug 11, 1988 | SESE |
| K864210 | MICROSELECTRON-HDR (HIGH DOSE RATE) | Nucletron-Oldelft Corp. | Nov 26, 1986 | SESE |
| K853912 | MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS | Nucletron-Oldelft Corp. | May 21, 1986 | SESE |
| K852842 | SELECTRON HDR REMOTE AFTERLOADER | Nucletron-Oldelft Corp. | Jan 10, 1986 | SESE |
Top Applicants
- Varian Medical Systems, Inc. — 50 clearances
- Mick Radio-Nuclear Instruments, Inc. — 22 clearances
- Nucletron Corp. — 14 clearances
- Nucletron Corporation — 10 clearances
- Varian Medical Systems — 8 clearances
