510(k) Report

Devices descending from K992577

20 later devices reach Photon Radiosurgery System (PRS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+1K111299Axxent Radiation Shield - RigidXoft, an Icad Company20110—
+1K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058—
+1K051055Intrabeam SystemCarl Zeiss Surgical GmbH200592
+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—
+2K090914Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc.20091—
+2K072683Axxent Electronic Brachytherapy SystemXoft, Inc.20085—
+3K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.20190—
+3K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+3K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.20134—
+4K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+4K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.20161—
+4K132092EsteyaNucletron B.V.20131—
+5K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+5K213942EsteyaNucletron B.V.20220—
+5K182641Sensus IORT SystemSensus Healthcare, Inc.20190—
+5K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+5K180308PreludeMedcom GmbH20180—