510(k) Report

Devices descending from K033371

29 later devices reach Varian Intracavitary Brachytherapy Applicators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151657Shielded Applicator Set, Cervical StopVarian Medical Systems, Inc.20151—
+1K141490Universal Segmented Cylinder Applicator Set and Universal Stump Applicator SetVarian Medical Systems, Inc.20144—
+1K123941Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder SetSpencer Fillmore20131—
+1K081677Savi Applicator KitCianna Medical, Inc.200811—
+1K072616Axxent Vaginal ApplicatorXoft, Inc.20080—
+1K070659Biolucent Applicator KitBiolucent, Inc.200713—
+1K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—
+1K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorMick Radio-Nuclear Instruments, Inc.20043—
+2K240495Flexible Fixation Device for Gynecological Applicators (GM11001960)Varian Medical Systems, Inc.20240—
+2K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+2K160610Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and…Kobold, LLC20170—
+2K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc.20163—
+2K141343Axxent Cervical ApplicatorIcad, Inc.20140—
+2K092405Mammosite Multi LumenHologic, Inc.20090—
+2K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+2K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+2K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.20061—
+3K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc.20182—
+3K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+4K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+4K193240Universal Cylinder Applicator FamilyVarian Medical Systems, Inc.20201—
+4K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+4K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+5K252717MAASTRO Rectal Applicator SetVarian Medical Systems20260—
+5K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+6K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+7K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+7K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+7K180308PreludeMedcom GmbH20180—