510(k) Report

Devices descending from K081079

11 later devices reach Contura MLB Source Applicator for Brachytherapy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132097Best Multi-Lumen Balloon Applicator for BrachytherapyBest Medical International, Inc.20130—
+1K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+2K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+3K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+3K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+3K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+4K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+5K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+6K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+6K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+6K180308PreludeMedcom GmbH20180—