510(k) Report

Devices descending from K983436

55 later devices reach Gammamed Plus High Dose Rate Remote Afterloading System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241965Catheter Surface Flap Applicator Set (GM11011830)Varian Medical Systems20240—
+1K172533GM Implant Tubes, Length Cutting GaugeVarian Medical Systems, Inc.20180—
+1K162533Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.20171—
+1K162615Mould Applicator SetVarian Medical Systems, Inc.20171—
+1K160045Heyman Packing Applicator SetVarian Medical Systems, Inc.20161—
+1K151022Intraluminal Applicator SetVarian Medical Systems, Inc.20151—
+1K123815Surface Applicator Set with Leipzig-Style ConeVarian Medical Systems, Inc.201311
+1K082653Centering Intraluminal ApplicatorVarian Medical Systems, Inc.20081—
+1K071381Gammamedplus IX Series HDR AfterloaderVarian Medical Systems20075—
+1K063815Varian Esophagus Bougie ApplicatorVarian Medical Systems20071—
+1K040541Mammosource High Dose Rate (HDR) Remote AfterloaderVarian Medical Systems, Inc.200401
+1K033371Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems2003292
+1K031524Gammamed Plus 3/24 HDR Remote AfterloaderVarian Medical Systems, Inc.200371
+2K241764Mould Probe MR SafeVarian Medical Systems, Inc.20250—
+2K242961Intraluminal Applicator SetVarian Medical Systems20240—
+2K241386Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc.20240—
+2K232949Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.20240—
+2K162499Best Instruminal ApplicatorBest Medical International, Inc.20180—
+2K162018Surface Applicator SetVarian Medical Systems, Inc.20170—
+2K151657Shielded Applicator Set, Cervical StopVarian Medical Systems, Inc.20151—
+2K141490Universal Segmented Cylinder Applicator Set and Universal Stump Applicator SetVarian Medical Systems, Inc.20144—
+2K123941Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder SetSpencer Fillmore20131—
+2K120993Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderVarian Medical Systems, Inc.20124—
+2K082530Applicators for Afterloading BrachytherapyIsodose Control B.V.20080—
+2K081677Savi Applicator KitCianna Medical, Inc.200811—
+2K072616Axxent Vaginal ApplicatorXoft, Inc.20080—
+2K070574FlexitronIsodose Control B.V.200701
+2K070659Biolucent Applicator KitBiolucent, Inc.200713—
+2K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—
+2K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorMick Radio-Nuclear Instruments, Inc.20043—
+3K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)Varian Medical Systems, Inc.20240—
+3K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+3K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc.20182—
+3K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and…Kobold, LLC20170—
+3K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc.20163—
+3K142986SagiNovaEckert & Ziegler Bebig GmbH20150—
+3K141343Axxent Cervical ApplicatorIcad, Inc.20140—
+3K092405Mammosite Multi LumenHologic, Inc.20090—
+3K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+3K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+3K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.20061—
+4K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc.20191—
+4K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc.20182—
+4K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+5K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+5K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc.20220—
+5K193240Universal Cylinder Applicator FamilyVarian Medical Systems, Inc.20201—
+5K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+5K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+6K252717MAASTRO Rectal Applicator SetVarian Medical Systems20260—
+6K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+7K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+8K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+8K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+8K180308PreludeMedcom GmbH20180—