510(k) Report

Devices descending from K980526

11 later devices reach Photon Radiosurgery System PRS400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110590Intrabeam Needle ApplicatorCarl Zeiss Surgical GmbH201221
+1K051055Intrabeam SystemCarl Zeiss Surgical GmbH200592
+2K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+2K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+3K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+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—