System, Applicator, Radionuclide, Remote-Controlled
FDA product code JAQ · Class II (moderate risk) · 21 CFR 892.5700 · Radiology
208510(k) clearances
0PMA approvals
36recalls
Manufacturers
- Varian Medical Systems, Inc. 59
- Nucletron Corp. 26
- Mick Radio-Nuclear Instruments, Inc. 22
- Nucletron B.V. 9
- Nucletron-Oldelft Corp. 7
- Alpha-Omega Services, Inc. 6
- Varian Assoc., Inc. 5
- Senorx, Inc. 5
- Omnitron Intl., Inc. 4
- Cianna Medical, Inc. 4
- Proxima Therapeutics, Inc. 4
- Hologic, Inc. 3
- Biolucent, Inc. 3
- Best Medical International, Inc. 3
- Cook, Inc. 3
- Standard Imaging, Inc. 3
- Spencer Fillmore 3
- Rts Technology, Inc. 3
- Kobold, LLC 3
- Isodose Control B.V. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | Varian Medical Systems | 05/20/2026SE |
| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
| K250299 | CT/ MR Tandem and Ovoid SetJAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2025SE |
| K250289 | Intracavitary/Interstitial SystemJAQ · Traditional | Varian Medical Systems | 04/25/2025SE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional | Varian Medical Systems, Inc. | 03/03/2025SE |
| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveJAQ · Traditional | Varian Medical Systems, Inc. | 11/07/2024SE |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830)JAQ · Traditional | Varian Medical Systems | 10/29/2024SE |
| K241386 | Heyman Packing Applicator Set (GM11004580)JAQ · Traditional | Varian Medical Systems, Inc. | 08/30/2024SE |
| K233628 | AOS Interstitial Templates, Needles, and AccessoriesJAQ · Traditional | Alpha-Omega Services, Inc. | 07/10/2024SE |
| K233626 | AOS Marker Seeds (SMG0242-025)JAQ · Traditional | Alpha-Omega Services, Inc. | 07/02/2024SE |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960)JAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2024SE |
| K232623 | Universal Endometrial Applicator Set (GM11009840)JAQ · Traditional | Varian Medical Systems, Inc. | 04/09/2024SE |
| K232949 | Kelowna GYN and Crook Prostate TemplatesJAQ · Traditional | Varian Medical Systems, Inc. | 02/01/2024SE |
| K230155 | Mick Valencia Applicator SetJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 08/30/2023SE |
| K222775 | Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems, Inc. | 03/13/2023SE |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…JAQ · Traditional | Varian Medical Systems, Inc. | 09/14/2022SE |
| K193240 | Universal Cylinder Applicator FamilyJAQ · Traditional | Varian Medical Systems, Inc. | 08/17/2020SE |
| K201272 | GenevaJAQ · Traditional | Nucletron B.V. | 07/16/2020SE |
| K201279 | ASSISTO Universal Applicator Clamping DeviceJAQ · Traditional | Geomed Medizin-Technik GmbH & Co. KG | 07/10/2020SE |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…JAQ · Special | Mick Radio-Nuclear Instruments, Inc. | 02/28/2020SE |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceJAQ · Special | Varian Medical Systems, Inc. | 07/08/2019SE |
| K183332 | BRAXX Esophageal Brachytherapy ApplicatorJAQ · Traditional | Braxx Biotech Co., Ltd. | 04/16/2019SE |
| K172533 | GM Implant Tubes, Length Cutting GaugeJAQ · Traditional | Varian Medical Systems, Inc. | 10/22/2018SE |
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…JAQ · Traditional | Varian Medical Systems, Inc. | 10/03/2018SE |
| K172675 | Varian Cervical SleevesJAQ · Traditional | Varian Medical Systems, Inc. | 05/16/2018SE |
| K180069 | HDR MRI Lumen MarkerJAQ · Traditional | C4 Imaging, LLC | 04/27/2018SE |
| K162499 | Best Instruminal ApplicatorJAQ · Traditional | Best Medical International, Inc. | 04/13/2018SE |
| K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…JAQ · Special | Varian Medical Systems, Inc. | 03/21/2018SE |
| K171631 | Standard Catheter SetJAQ · Traditional | Varian Medical Systems, Inc. | 02/09/2018SE |
| K162533 | Kelowna GYN and Crook Prostate TemplatesJAQ · Traditional | Varian Medical Systems, Inc. | 08/31/2017SE |
| K170203 | System, Applicator, Radionuclide, Remote ControlledJAQ · Traditional | Kobold, LLC | 06/01/2017SE |
| K162615 | Mould Applicator SetJAQ · Traditional | Varian Medical Systems, Inc. | 03/24/2017SE |
| K160815 | Interstitial NeedlesJAQ · Traditional | Varian Medical Systems, Inc. | 03/10/2017SE |
| K162018 | Surface Applicator SetJAQ · Traditional | Varian Medical Systems, Inc. | 02/28/2017SE |
| K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and…JAQ · Traditional | Kobold, LLC | 02/13/2017SE |
| K161688 | Advanced Gynecological ApplicatorJAQ · Traditional | Nucletron B.V. | 01/27/2017SE |
| K160045 | Heyman Packing Applicator SetJAQ · Traditional | Varian Medical Systems, Inc. | 11/17/2016SE |
| K161540 | Advanced Breast Template SystemJAQ · Traditional | Varian Medical Systems, Inc. | 10/20/2016SE |
| K161576 | Esophagus Bougie SetJAQ · Traditional | Varian Medical Systems, Inc. | 10/02/2016SE |
| K160516 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…JAQ · Traditional | Varian Medical Systems, Inc. | 08/10/2016SE |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN TemplateJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 05/31/2016SE |
| K160021 | Varian Sterilization BoxesJAQ · Traditional | Varian Medical Systems, Inc. | 04/13/2016SE |
| K151022 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems, Inc. | 12/17/2015SE |
| K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker SetsJAQ · Traditional | Varian Medical Systems, Inc. | 09/11/2015SE |
| K151657 | Shielded Applicator Set, Cervical StopJAQ · Traditional | Varian Medical Systems, Inc. | 08/07/2015SE |
| K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring…JAQ · Traditional | Varian Medical Systems, Inc. | 07/17/2015SE |
| K151272 | Henschke Titanium Applicator SetJAQ · Traditional | Nucletron B.V. | 06/23/2015SE |
| K142719 | E-AppJAQ · Traditional | Gc Medtech, LLC | 05/20/2015SE |
| K142986 | SagiNovaJAQ · Traditional | Eckert & Ziegler Bebig GmbH | 04/17/2015SE |
| K142330 | Kobold Ring and Tandem Applicator SetJAQ · Traditional | Kobold, LLC | 04/09/2015SE |
| K142439 | Martinez Prostate Template SetJAQ · Traditional | Nucletron B.V. | 03/10/2015SE |
| K141624 | Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with…JAQ · Traditional | Varian Medical Systems, Inc. | 03/10/2015SE |
| K142597 | Vienna SystemJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 02/19/2015SE |
| K141490 | Universal Segmented Cylinder Applicator Set and Universal Stump Applicator SetJAQ · Traditional | Varian Medical Systems, Inc. | 09/26/2014SE |
| K141336 | Source Guide Tube with Locking Mechanism for 113 MM Needles, GammamedplusJAQ · Traditional | Varian Medical Systems, Inc. | 08/06/2014SE |
| K140803 | Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMJAQ · Traditional | Nucletron B.V. | 06/26/2014SE |
| K133922 | Gentlecare Ar ApplicatorJAQ · Traditional | Gc Medtech, LLC | 04/18/2014SE |
| K130757 | Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube SetJAQ · Traditional | Spencer Fillmore | 04/03/2014SE |
| K132889 | Fletcher Ct/Mr Shielded Applicator Set (6 MM) Fletcher Ct/Mr Shielded Applicator Set (4…JAQ · Traditional | Nucletron B.V. | 02/26/2014SE |
| K132874 | Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure Set 5F…JAQ · Special | Nucletron B.V. | 02/21/2014SE |
| K132097 | Best Multi-Lumen Balloon Applicator for BrachytherapyJAQ · Traditional | Best Medical International, Inc. | 09/30/2013SE |
| K123912 | Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetJAQ · Traditional | Spencer Fillmore | 05/14/2013SE |
| K123941 | Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder SetJAQ · Traditional | Spencer Fillmore | 04/30/2013SE |
| K130251 | Esophagus Bougie SetJAQ · Traditional | Varian Medical Systems, Inc. | 03/13/2013SE |
| K123815 | Surface Applicator Set with Leipzig-Style ConeJAQ · Traditional | Varian Medical Systems, Inc. | 03/11/2013SE |
| K123442 | Xoft Axxent Cervical ApplicatorsJAQ · Traditional | Icad, Inc. | 02/27/2013SE |
| K122840 | CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407JAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 12/14/2012SE |
| K122236 | Varisourse Ix Brahytherapy Afterloader Varisource Ix (T) Brachytherapy AfterloaderJAQ · Traditional | Varian Medical Systems, Inc. | 11/16/2012SE |
| K120993 | Gammamedplus Ix Brachytherapy Afterloader, Gammamedplus 3/24 Ix Brachytherapy AfterloaderJAQ · Traditional | Varian Medical Systems, Inc. | 07/26/2012SE |
| K120731 | Titanium Fletcher-Style Applicator Set-Defined GeometryJAQ · Traditional | Varian Medical Systems, Inc. | 06/06/2012SE |
| K120344 | Radiapak Brachytherapy Applicator Balloon DeviceJAQ · Traditional | Radiadyne, LLC (Specification Developer) | 05/03/2012SE |
| K120341 | Plastic Needle with Mandrin 2.0 Diameter Length 113MMJAQ · Traditional | Varian Medical Systems, Inc. | 04/27/2012SE |
| K113766 | Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer…JAQ · Traditional | Varian Medical Systems, Inc. | 03/16/2012SE |
| K112420 | Oncentra Prostate 4.0JAQ · Traditional | Nucletron | 11/18/2011SE |
| K111973 | Vaginal CT / MR Multi Channel Applicator SetJAQ · Special | Nucletron | 09/21/2011SE |
| K103215 | Cianna S1, Single Lumen Balloon Applicator KitJAQ · Traditional | Cianna Medical | 11/15/2010SE |
| K101411 | Savi Preparation DeviceJAQ · Traditional | Cianna Medical, Inc. | 07/12/2010SE |
| K092534 | Alatus Vaginal Balloon Packing SystemJAQ · Traditional | Radiadyne | 12/07/2009SE |
| K093291 | Varian Interstitial Titanium NeedlesJAQ · Special | Varian Medical Systems, Inc. | 11/17/2009SE |
| K092822 | Capri ApplicatorJAQ · Traditional | Vivaray, Inc. | 11/03/2009SE |
| K092804 | Microselectron HDR V2, Model 105.999JAQ · Special | Nucletron Corp. | 10/08/2009SE |
| K092405 | Mammosite Multi LumenJAQ · Special | Hologic, Inc. | 08/27/2009SESU |
| K092323 | Contura Cavity Maintenance CatheterJAQ · Traditional | Senorx, Inc. | 08/19/2009SE |
| K091230 | HDR Prostate Template and AccessoriesJAQ · Traditional | Photon Technologies Corporation | 08/12/2009SE |
| K091378 | Mammosite II Radiation Therapy SystemJAQ · Special | Hologic, Inc. | 07/02/2009SESU |
| K091598 | Lumencath Applicator Set, Models 189. 795, 189.796, 189.797, 189.798, Lumencath CathetersJAQ · Special | Nucletron Corp. | 06/29/2009SE |
| K091154 | Utrecht Interstitial Fletcher Ct/Mr Applicator Set, Model 110.270, Interstitial Ring…JAQ · Special | Nucletron Corporation | 05/18/2009SE |
| K082530 | Applicators for Afterloading BrachytherapyJAQ · Abbreviated | Isodose Control B.V. | 10/30/2008SE |
| K082653 | Centering Intraluminal ApplicatorJAQ · Special | Varian Medical Systems, Inc. | 10/10/2008SE |
| K082264 | Contura Lumen MarkerJAQ · Traditional | Senorx, Inc. | 09/12/2008SESU |
| K081677 | Savi Applicator KitJAQ · Special | Cianna Medical, Inc. | 07/22/2008SESU |
| K080934 | Vienna Ring Ct/Mr Applicator Set, Round Point Titanium Needle Set, Trocar Point Titanium…JAQ · Traditional | Nucletron Corporation | 05/28/2008SE |
| K081179 | Mammosite Cavity Evaluation DeviceJAQ · Traditional | Hologic, Inc. | 05/09/2008SE |
| K081079 | Contura MLB Source Applicator for BrachytherapyJAQ · Traditional | Senorx, Inc. | 05/02/2008SESU |
| K080791 | Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and…JAQ · Traditional | Senorx, Inc. | 04/30/2008SESU |
| K080871 | Trocar Point Titanium Needle Sets, Round Point Titanium Needle SetsJAQ · Special | Nucletron Corporation | 04/29/2008SE |
| K080565 | Modification to: Savi Applicator KitJAQ · Special | Cianna Medical, Inc. | 04/04/2008SESU |
| K073107 | Valencia Skin Applicator Set, Model: 189.701JAQ · Special | Nucletron Corporation | 12/07/2007SE |
| K073133 | Interstitial NeedlesJAQ · Special | Varian Medical Systems, Inc. | 11/16/2007SE |
| K071381 | Gammamedplus Ix Series HDR AfterloaderJAQ · Traditional | Varian Medical Systems | 07/18/2007SE |
| K071467 | Varisource Ix HDR AfterloaderJAQ · Traditional | Varian Medical Systems, Inc. | 07/16/2007SE |
| K062824 | Aos Universal Conecting Guide TubeJAQ · Traditional | Alpha-Omega Services, Inc. | 07/03/2007SE |
| K062823 | Aos Interstitial Templates, Needles & AccessoriesJAQ · Traditional | Alpha-Omega Services, Inc. | 05/29/2007SE |
| K062826 | Aos Implant Tubes, Implant Needles & Retaining BottonsJAQ · Traditional | Alpha-Omega Services, Inc. | 05/22/2007SE |
| K071229 | Senorad Multi-Lumen Balloon Source Applicator for BranchytherapyJAQ · Traditional | Senorx, Inc. | 05/18/2007SESU |
| K070574 | FlexitronJAQ · Abbreviated | Isodose Control B.V. | 04/13/2007SE |
| K070659 | Biolucent Applicator KitJAQ · Special | Biolucent, Inc. | 04/04/2007SESU |
| K063815 | Varian Esophagus Bougie ApplicatorJAQ · Traditional | Varian Medical Systems | 03/01/2007SE |
| K063382 | HDR CT Compatible Split Ring ApplicatorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 12/26/2006SE |
| K063381 | CT Compatible F/S/D ApplicatorsJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 12/22/2006SE |
| K062241 | Adjustable Multi-Catheter Source ApplictorJAQ · Traditional | North American Scientific, Inc. | 11/09/2006SESU |
| K062135 | Art Shielded Breast ApplicatorJAQ · Traditional | Advanced Radiation Therapy, LLC | 11/07/2006SE |
| K062830 | Biolucent Applicator KitJAQ · Special | Biolucent, Inc. | 10/20/2006SE |
| K061354 | Microselectron V3, Model 106.990JAQ · Special | Nucletron Corporation | 08/17/2006SE |
| K061241 | Biolucent Applicator, Model Rta-XxJAQ · Traditional | Biolucent, Inc. | 07/28/2006SE |
| K061582 | Varisource 200 HDR AfterloaderJAQ · Traditional | Varian Medical Systems, Inc. | 07/25/2006SE |
| K060299 | Art Brachytherapy ApplicatorJAQ · Traditional | Advanced Radiation Therapy, LLC | 06/06/2006SE |
| K052947 | Source Production & Equipment Co, Inc., Model M-19 IR-192 Brachytherapy SourceJAQ · Traditional | Source Production & Equipment Co., Inc. | 04/19/2006SE |
| K060532 | HDR 1000 Plus Well Chamber, Model 90008JAQ · Traditional | Standard Imaging, Inc. | 04/11/2006SE |
| K051753 | Accu-SourceJAQ · Traditional | Oncology Systems, Inc. | 03/29/2006SE |
| K060349 | Proguide Needle SetJAQ · Special | Nucletron Corporation | 03/10/2006SE |
| K052228 | Smit SleeveJAQ · Traditional | Nucletron Corporation | 11/09/2005SE |
| K052595 | CRC 15ULTRAJAQ · Traditional | Capintec, Inc. | 11/08/2005SE |
| K052351 | HDR Iort Shielded ApplicatorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 10/17/2005SE |
| K051423 | Mick HDR Interstitial Implant AccessoriesJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 07/01/2005SE |
| K041715 | Intracavitary Mould Applicator Set, Model 189.001JAQ · Traditional | Nucletron Corp. | 03/24/2005SE |
| K042360 | Varian Nasopharynx ApplicatorJAQ · Traditional | Varian Medical Systems, Inc. | 02/16/2005SE |
| K042586 | Best Breast Brachytherapy ApplicatorJAQ · Traditional | Best Medical International, Inc. | 11/03/2004SE |
| K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…JAQ · Special | Proxima Therapeutics, Inc. | 08/26/2004SE |
| K041933 | Microselectron PDRJAQ · Special | Nucletron Corp. | 08/18/2004SE |
| K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 06/18/2004SE |
| K040541 | Mammosource High Dose Rate (HDR) Remote AfterloaderJAQ · Special | Varian Medical Systems, Inc. | 03/22/2004SE |
| K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayJAQ · Traditional | Proxima Therapeutics, Inc. | 02/10/2004SE |
| K033828 | CT Compatible Intrauterine Sleeves, Cat #0311, 9406JAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 02/02/2004SE |
| K033371 | Varian Intracavitary Brachytherapy ApplicatorsJAQ · Traditional | Varian Medical Systems | 12/24/2003SE |
| K031524 | Gammamed Plus 3/24 HDR Remote AfterloaderJAQ · Traditional | Varian Medical Systems, Inc. | 11/26/2003SE |
| K032372 | Nucletron Comfort Catheter System, Model 189.007JAQ · Traditional | Nucletron Corporation | 08/15/2003SE |
| K031158 | Swift 2.0, Model 132.001JAQ · Special | Nucletron Corp. | 08/07/2003SE |
| K031273 | Ameritek Sure-Point HDR Needle TemplateJAQ · Traditional | Amertek Medical, Inc. | 07/15/2003SE |
| K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayJAQ · Traditional | Proxima Therapeutics, Inc. | 05/21/2003SE |
| K030110 | CT HDR Tandem/Ring Applicator with Rectal RetractorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 04/03/2003SE |
| K023220 | Varisource Breast Template SystemJAQ · Special | Varian Medical Systems | 10/25/2002SE |
| K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002JAQ · Special | Nucletron Corporation | 10/25/2002SE |
| K022635 | Kuske Breast Applicator Set, Model 189.006JAQ · Special | Nucletron Corporation | 09/06/2002SE |
| K021286 | Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115VOLT Devices and…JAQ · Special | Nucletron Corp. | 05/23/2002SE |
| K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayJAQ · Traditional | Proxima Therapeutics, Inc. | 05/06/2002SESU |
| K020176 | HDR Miami ApplicatorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 04/08/2002SE |
| K020015 | Implant Guidance System Applicator SetJAQ · Special | Nucletron Corp. | 03/13/2002SE |
| K010032 | Seed Selectron Model V. 1.0JAQ · Traditional | Nucletron Corp. | 10/17/2001SE |
| K011657 | HDR Tandem/Ring Applicator with Rectal RetractorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 08/27/2001SE |
| K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067JAQ · Special | Nucletron Corp. | 12/22/2000SE |
| K000081 | Manual and Remote Controlled Applicator SystemJAQ · Traditional | Isotopes and Metals , Ltd. | 12/19/2000SE |
| K001544 | Vaginal Applicator ShieldedJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 11/17/2000SE |
| K001825 | Standard Imaging HDR 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion ChamberJAQ · Special | Standard Imaging, Inc. | 08/02/2000SE |
| K993472 | Segmented Vaginal ApplicatorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 01/12/2000SE |
| K993400 | HDR Contour TP Template and Implant AccessoriesJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 01/06/2000SE |
| K990990 | Cet Prostate Applicator Set, Part Number 089.066JAQ · Traditional | Nucletron Corp. | 10/07/1999SE |
| K990753 | Grac High Dose Rate (HDR) Remote Afterloading CatheterJAQ · Traditional | Cook, Inc. | 05/27/1999SE |
| K983338 | Freiburg Flap Applicator Set, Part Number 089.095JAQ · Traditional | Nucletron Corp. | 04/20/1999SE |
| K983341 | Standard Ct/Mr Applicator Set,Ring Ct/Mr Applicator Set, Vaginal Ct/Mr Applicator Set…JAQ · Traditional | Nucletron Corp. | 04/15/1999SE |
| K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068JAQ · Traditional | Nucletron Corp. | 04/02/1999SE |
| K983115 | Treatment Control Station - Microselectron-Hdr Classic Upgrade, Version 1.20JAQ · Traditional | Nucletron Corp. | 04/02/1999SE |
| K981886 | Vrac High Dose Rate (HDR) Remote Afterloading CatheterJAQ · Traditional | Cook, Inc. | 11/03/1998SE |
| K980576 | Varian Endometrial Applicator for Varisource Remote High Dose Rate AfterloaderJAQ · Traditional | Varian Medical Systems, Inc. | 11/02/1998SE |
| K983436 | Gammamed Plus High Dose Rate Remote Afterloading SystemJAQ · Special | Gammamed USA | 10/29/1998SE |
| K980590 | Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate…JAQ · Traditional | Varian Medical Systems, Inc. | 10/22/1998SE |
| K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…JAQ · Traditional | Varian Assoc., Inc. | 10/21/1998SE |
| K964910 | Aos Universal Connecting Guide Tube for High Dose Rate AfterloadersJAQ · Traditional | Alpha-Omega Services, Inc. | 03/10/1997SE |
| K961601 | H.A.M. ApplicatorJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 12/23/1996SE |
| K953946 | Microselectron-Hdr Version 2JAQ · Traditional | Nucletron-Oldelft Corp. | 08/13/1996SE |
| K955844 | Applicators for Varian Varisource Remote High Dose Rate AfterloaderJAQ · Traditional | Varian Assoc., Inc. | 07/26/1996SE |
| K954467 | Cadplan BTJAQ · Traditional | Varian Assoc., Inc. | 03/15/1996SE |
| K952913 | Applicators for Varian Varisource Remote High Soes Rate AfterloaderJAQ · Traditional | Varian Assoc., Inc. | 11/22/1995SE |
| K945383 | High Dose Rate AfterloaderJAQ · Traditional | Varian Assoc., Inc. | 02/15/1995SE |
| K943109 | Remote Control Radioisotope ApplicatorJAQ · Traditional | Inter-Pal GmbH | 02/09/1995SE |
| K925956 | Microselectron - HDR for Mobile EnvironmentJAQ · Traditional | Nucletron-Oldelft Corp. | 11/19/1993SE |
| K923738 | High Dose Rate Remote Afterloading CatheterJAQ · Traditional | Cook, Inc. | 04/13/1993SE |
| K922564 | 6 French CatheterJAQ · Traditional | S. and H. Engineering, Inc. | 12/17/1992SE |
| K901615 | Pulmocath Intrabronchial CatheterJAQ · Traditional | Omnitron Intl., Inc. | 11/27/1992SE |
| K915622 | Plato Brachytheraphy Treatment Planning SystemJAQ · Traditional | Nucletron-Oldelft Corp. | 09/25/1992SE |
| K922554 | Standard Imaging HDR 1000 Ion ChamberJAQ · Traditional | Standard Imaging, Inc. | 08/24/1992SE |
| K920431 | Omnitron Needle Applicators 18 and 21 GaugeJAQ · Traditional | Omnitron Intl., Inc. | 05/29/1992SE |
| K915367 | HDRS-1 SystemJAQ · Traditional | Precision Radiation Measurement, Inc. | 04/06/1992SE |
| K913908 | Omnitron Gyn Applicator SystemJAQ · Traditional | Omnitron Intl., Inc. | 03/06/1992SE |
| K914578 | RTS Technology Models 721,722,723,724JAQ · Traditional | Rts Technology, Inc. | 02/28/1992SE |
| K912555 | Gammamed 12IT High Dose Rate Remote AfterloaderJAQ · Traditional | Rts Technology, Inc. | 08/02/1991SE |
| K902533 | Pulsed SelectronJAQ · Traditional | Nucletron-Oldelft Corp. | 10/12/1990SE |
| K901589 | RTS Technology Iridium 192 SourcesJAQ · Traditional | Rts Technology, Inc. | 08/17/1990SE |
| K890294 | Inter-Pal C-19 and Inter-Pal C-38JAQ · Traditional | Enrad Corp. | 02/01/1990SE |
| K894381 | Gammamed IRIDIUM-192 SourceJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 11/21/1989SE |
| K890799 | Curietron 192 High Dose RateJAQ · Traditional | Cis-Us, Inc. | 10/27/1989SE |
| K891131 | Gammamed 12IJAQ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 08/07/1989SE |
| K881323 | Curietron 192 Low Dose RateJAQ · Traditional | Compagnie Oris Industrie, S.A. | 01/17/1989SE |
| K881665 | Omnitron Remote Controlled Radionuclide ApplicatorJAQ · Traditional | Omnitron Intl., Inc. | 08/11/1988SE |
| K864210 | Microselectron-Hdr (High Dose Rate)JAQ · Traditional | Nucletron-Oldelft Corp. | 11/26/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2712-2026 Class II | Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The…Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may… | Elekta, Inc. | 04/03/2026Open, Classified |
| Z-2711-2026 Class II | Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator…Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may… | Elekta, Inc. | 04/03/2026Open, Classified |
| Z-2710-2026 Class II | Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote…Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may… | Elekta, Inc. | 04/03/2026Open, Classified |
| Z-0772-2020 Class II | There is a complaint regarding internal check cable guide mechanism failure for the…A component failure may lead to treatment interruption or incorrect source positioning. | Nucletron BV | 11/18/2019Terminated |
| Z-1849-2015 Class II | The VariSource iX series afterloader systems are computer controlled remote…After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction… | Varian Medical Systems Inc | 05/18/2015Terminated |
| Z-1829-2015 Class II | Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style… | Varian Medical Systems Inc | 05/18/2015Terminated |
| Z-0065-2014 Class II | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR…The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template… | Varian Medical Systems, Inc. | 08/09/2013Terminated |
| Z-0607-2013 Class II | Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube…The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical… | Varian Medical Systems, Inc. | 09/28/2012Terminated |
| Z-0760-2013 Class II | Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and…A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or… | Varian Medical Systems, Inc. | 04/12/2012Terminated |
| Z-0759-2013 Class II | Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical…A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or… | Varian Medical Systems, Inc. | 04/12/2012Terminated |
| Z-1200-2012 | Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3…Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to… | Varian Medical Systems, Inc. | 01/05/2012Terminated |
| Z-1199-2012 | Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used…Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to… | Varian Medical Systems, Inc. | 01/05/2012Terminated |
| Z-0330-2012 | Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm…The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the… | Varian Medical Systems, Inc. Oncology Systems | 10/06/2011Terminated |
| Z-0329-2012 | Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm…The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the… | Varian Medical Systems, Inc. Oncology Systems | 10/06/2011Terminated |
| Z-3055-2011 | Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented…Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment… | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-3013-2011 | GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. Varian Medical Systems…Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent… | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-3000-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2999-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2998-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2997-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2996-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2995-2011 | Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium…Potential of weld failure of the Titanium intrauterine probe at the cervical stopper. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2993-2011 | GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 320 mm. Remote controlled…Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2992-2011 | GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 200 mm. Remote controlled…Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-2991-2011 | GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled…Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. | Varian Medical Systems, Inc. Oncology Systems | 07/13/2011Terminated |
| Z-0282-2012 | Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the…The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the… | Varian Medical Systems, Inc. | 05/20/2010Terminated |
| Z-0325-2012 | VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader.…VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in… | Varian Medical Systems, Inc. | 03/01/2010Terminated |
| Z-1318-2009 | Mammo Test Model number 10144185, x-ray guided stereotactic biopsy systemTable may unintentionally lift during procedure | Siemens Medical Solutions USA, Inc | 01/21/2009Terminated |
| Z-0328-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled…Plastic needle tip could possibly crack or separate. | Varian Medical Systems, Inc. | 09/30/2008Terminated |
| Z-0327-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled…Plastic needle tip could possibly crack or separate. | Varian Medical Systems, Inc. | 09/30/2008Terminated |
| Z-0326-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled…Plastic needle tip could possibly crack or separate. | Varian Medical Systems, Inc. | 09/30/2008Terminated |
| Z-0295-2012 | GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF.…GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent… | Varian Medical Systems, Inc. | 08/05/2008Terminated |
| Z-2081-2008 | VariSource CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm…Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy… | Varian Medical Systems, Inc. | 03/12/2008Terminated |
| Z-0487-2007 | GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.Medical device for patient treatment does not meet electrical safety standards. | Varian Medical Systems | 09/11/2006Terminated |
| Z-0486-2007 | GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems…Medical device for patient treatment does not meet electrical safety standards. | Varian Medical Systems | 09/11/2006Terminated |
| Z-1324-2013 Class II | Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate…Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas… | Varian Medical Systems, Inc. | 04/11/0013Terminated |