510(k) Report

Devices descending from K080565

12 later devices reach Modification to: Savi Applicator Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081677Savi Applicator KitCianna Medical, Inc.200811—
+2K092405Mammosite Multi LumenHologic, Inc.20090—
+2K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+3K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+4K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+4K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+4K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+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—