510(k) Report

Devices descending from K091378

9 later devices reach Mammosite II Radiation Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+2K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+2K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+2K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+3K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+4K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+5K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+5K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+5K180308PreludeMedcom GmbH20180—