510(k) Report

Devices descending from K961601

28 later devices reach H.a.M. Applicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc.20062—
+1K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc.200617—
+1K060299Art Brachytherapy ApplicatorAdvanced Radiation Therapy, LLC20061—
+1K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc.20051—
+1K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc.20002—
+1K983338Freiburg Flap Applicator Set, Part Number 089.095Nucletron Corp.19992—
+2K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+2K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc.20160—
+2K092822Capri ApplicatorVivaray, Inc.20092—
+2K082530Applicators for Afterloading BrachytherapyIsodose Control B.V.20080—
+2K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+2K070659Biolucent Applicator KitBiolucent, Inc.200713—
+2K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—
+2K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc.20030—
+3K133922Gentlecare AR ApplicatorGc Medtech, LLC20140—
+3K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer)20120—
+3K081677Savi Applicator KitCianna Medical, Inc.200811—
+4K092405Mammosite Multi LumenHologic, Inc.20090—
+4K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+5K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+6K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+6K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+6K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+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—