510(k) Report

Devices descending from K912555

56 later devices reach Gammamed 12IT High Dose Rate Remote Afterloader through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983436Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA19985517
+2K241965Catheter Surface Flap Applicator Set (GM11011830)Varian Medical Systems20240—
+2K172533GM Implant Tubes, Length Cutting GaugeVarian Medical Systems, Inc.20180—
+2K162533Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.20171—
+2K162615Mould Applicator SetVarian Medical Systems, Inc.20171—
+2K160045Heyman Packing Applicator SetVarian Medical Systems, Inc.20161—
+2K151022Intraluminal Applicator SetVarian Medical Systems, Inc.20151—
+2K123815Surface Applicator Set with Leipzig-Style ConeVarian Medical Systems, Inc.201311
+2K082653Centering Intraluminal ApplicatorVarian Medical Systems, Inc.20081—
+2K071381Gammamedplus IX Series HDR AfterloaderVarian Medical Systems20075—
+2K063815Varian Esophagus Bougie ApplicatorVarian Medical Systems20071—
+2K040541Mammosource High Dose Rate (HDR) Remote AfterloaderVarian Medical Systems, Inc.200401
+2K033371Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems2003292
+2K031524Gammamed Plus 3/24 HDR Remote AfterloaderVarian Medical Systems, Inc.200371
+3K241764Mould Probe MR SafeVarian Medical Systems, Inc.20250—
+3K242961Intraluminal Applicator SetVarian Medical Systems20240—
+3K241386Heyman Packing Applicator Set (GM11004580)Varian Medical Systems, Inc.20240—
+3K232949Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.20240—
+3K162499Best Instruminal ApplicatorBest Medical International, Inc.20180—
+3K162018Surface Applicator SetVarian Medical Systems, Inc.20170—
+3K151657Shielded Applicator Set, Cervical StopVarian Medical Systems, Inc.20151—
+3K141490Universal Segmented Cylinder Applicator Set and Universal Stump Applicator SetVarian Medical Systems, Inc.20144—
+3K123941Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder SetSpencer Fillmore20131—
+3K120993Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderVarian Medical Systems, Inc.20124—
+3K082530Applicators for Afterloading BrachytherapyIsodose Control B.V.20080—
+3K081677Savi Applicator KitCianna Medical, Inc.200811—
+3K072616Axxent Vaginal ApplicatorXoft, Inc.20080—
+3K070574FlexitronIsodose Control B.V.200701
+3K070659Biolucent Applicator KitBiolucent, Inc.200713—
+3K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—
+3K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorMick Radio-Nuclear Instruments, Inc.20043—
+4K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)Varian Medical Systems, Inc.20240—
+4K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+4K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc.20182—
+4K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and…Kobold, LLC20170—
+4K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc.20163—
+4K142986SagiNovaEckert & Ziegler Bebig GmbH20150—
+4K141343Axxent Cervical ApplicatorIcad, Inc.20140—
+4K092405Mammosite Multi LumenHologic, Inc.20090—
+4K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+4K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+4K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.20061—
+5K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc.20191—
+5K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc.20182—
+5K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+6K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+6K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc.20220—
+6K193240Universal Cylinder Applicator FamilyVarian Medical Systems, Inc.20201—
+6K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+6K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+7K252717MAASTRO Rectal Applicator SetVarian Medical Systems20260—
+7K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+8K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+9K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+9K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+9K180308PreludeMedcom GmbH20180—