510(k) Report

Devices descending from K953946

106 later devices reach Microselectron-HDR Version 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161688Advanced Gynecological ApplicatorNucletron B.V.201701
+1K151272Henschke Titanium Applicator SetNucletron B.V.20150—
+1K142986SagiNovaEckert & Ziegler Bebig GmbH20150—
+1K140803Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMNucletron B.V.20140—
+1K111973Vaginal CT / MR Multi Channel Applicator SetNucletron20110—
+1K092822Capri ApplicatorVivaray, Inc.20092—
+1K092804Microselectron HDR V2, Model 105.999Nucletron Corp.20091—
+1K080934Vienna Ring CT/MR Applicator Set, Round Point Titanium Needle Set, Trocar Point Titanium…Nucletron Corporation20081—
+1K080871Trocar Point Titanium Needle Sets, Round Point Titanium Needle SetsNucletron Corporation20080—
+1K073107Valencia Skin Applicator Set, Model: 189.701Nucletron Corporation20077—
+1K070574FlexitronIsodose Control B.V.200701
+1K052947Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy SourceSource Production & Equipment Co., Inc.200611
+1K051753Accu-SourceOncology Systems, Inc.20060—
+1K060349Proguide Needle SetNucletron Corporation20062—
+1K052228Smit SleeveNucletron Corporation20050—
+1K041715Intracavitary Mould Applicator Set, Model 189.001Nucletron Corp.20051—
+1K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp.20054—
+1K041933Microselectron PDRNucletron Corp.20048—
+1K022635Kuske Breast Applicator Set, Model 189.006Nucletron Corporation20020—
+1K021286Microselectron HDR- Genie Afterloading System, Model 105.989 for 115VOLT Devices and…Nucletron Corp.20020—
+1K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200234—
+1K020176HDR Miami ApplicatorMick Radio-Nuclear Instruments, Inc.20022—
+1K020015Implant Guidance System Applicator SetNucletron Corp.200220—
+1K011657HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc.2001132
+1K992577Photon Radiosurgery System (PRS)Photoelectron Corporation199920—
+1K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set…Nucletron Corp.199942—
+1K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp.199936—
+1K983115Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20Nucletron Corp.19990—
+2K251037Rectal ApplicatorNucletron B.V.20250—
+2K230155Mick Valencia Applicator SetMick Radio-Nuclear Instruments, Inc.20230—
+2K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+2K161396SPEC Model M23Source Production and Equipment Co., Inc.20160—
+2K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc.20160—
+2K142597Vienna SystemMick Radio-Nuclear Instruments, Inc.20150—
+2K133922Gentlecare AR ApplicatorGc Medtech, LLC20140—
+2K132889Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded Applicator Set (4…Nucletron B.V.201401
+2K132092EsteyaNucletron B.V.20131—
+2K123912Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetSpencer Fillmore20132—
+2K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+2K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer)20120—
+2K111299Axxent Radiation Shield - RigidXoft, an Icad Company20110—
+2K102811Aos Orion IR-192 Source CableAlpha-Omega Services, Inc.20110—
+2K092522ACU007SOncology Systems, Inc.20090—
+2K091154Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring…Nucletron Corporation20094—
+2K090366Spec Model M-31Source Production & Equipment Co., Inc.20091—
+2K083734Axxent Surface Applicator, Model 710257Xoft, Inc.20093—
+2K082530Applicators for Afterloading BrachytherapyIsodose Control B.V.20080—
+2K082264Contura Lumen MarkerSenorx, Inc.20080—
+2K081179Mammosite Cavity Evaluation DeviceHologic, Inc.20082—
+2K070468Implant Sciences Corp. Model HDR 4454Implant Sciences Corp.20070—
+2K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc.20062—
+2K061354Microselectron V3, Model 106.990Nucletron Corporation20067—
+2K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058—
+2K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc.20051—
+2K051055Intrabeam SystemCarl Zeiss Surgical GmbH200592
+2K042360Varian Nasopharynx ApplicatorVarian Medical Systems, Inc.20050—
+2K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…Proxima Therapeutics, Inc.200417—
+2K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.20049—
+2K032372Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation200319—
+2K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200333—
+2K030110CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc.200391
+3K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+3K213942EsteyaNucletron B.V.20220—
+3K201272GenevaNucletron B.V.202011
+3K180069HDR MRI Lumen MarkerC4 Imaging, LLC20180—
+3K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and…Kobold, LLC20170—
+3K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+3K1508393D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring…Varian Medical Systems, Inc.20152—
+3K142330Kobold Ring and Tandem Applicator SetKobold, LLC20150—
+3K141038Ant Model 1Advanced Nuclide Technologies, LLC20140—
+3K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+3K130549Intrabeam Flat Applicator, Intrabeam Surface ApplicatorCarl Zeiss Meditec, Inc.201321
+3K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc.20122—
+3K120993Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderVarian Medical Systems, Inc.20124—
+3K103215Cianna S1, Single Lumen Balloon Applicator KitCianna Medical20100—
+3K101411Savi Preparation DeviceCianna Medical, Inc.20100—
+3K092405Mammosite Multi LumenHologic, Inc.20090—
+3K092323Contura Cavity Maintenance CatheterSenorx, Inc.20091—
+3K090914Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc.20091—
+3K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+3K081677Savi Applicator KitCianna Medical, Inc.200811—
+3K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc.200811—
+3K072683Axxent Electronic Brachytherapy SystemXoft, Inc.20085—
+3K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc.200714—
+3K070659Biolucent Applicator KitBiolucent, Inc.200713—
+3K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.20061—
+3K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—
+3K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc.200617—
+4K250289Intracavitary/Interstitial SystemVarian Medical Systems20250—
+4K222775Aarhus Applicator SetVarian Medical Systems, Inc.20231—
+4K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.20190—
+4K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc.20182—
+4K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+4K132097Best Multi-Lumen Balloon Applicator for BrachytherapyBest Medical International, Inc.20130—
+4K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.20134—
+4K080791Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and…Senorx, Inc.20080—
+4K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+5K252884Guided Aarhus Applicator SetVarian Medical Systems20250—
+5K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc.20191—
+5K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—