510(k) Report

Devices descending from K945383

27 later devices reach High Dose Rate Afterloader through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061582Varisource 200 HDR AfterloaderVarian Medical Systems, Inc.20068—
+1K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058—
+1K992577Photon Radiosurgery System (PRS)Photoelectron Corporation199920—
+1K990753Grac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc.19990—
+1K981886Vrac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc.19981—
+1K954467Cadplan BTVarian Assoc., Inc.19960—
+2K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.20134—
+2K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+2K111299Axxent Radiation Shield - RigidXoft, an Icad Company20110—
+2K090914Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc.20091—
+2K072683Axxent Electronic Brachytherapy SystemXoft, Inc.20085—
+2K071467Varisource IX HDR AfterloaderVarian Medical Systems, Inc.200713
+2K051055Intrabeam SystemCarl Zeiss Surgical GmbH200592
+3K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+3K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.20190—
+3K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+3K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.20161—
+3K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+3K132092EsteyaNucletron B.V.20131—
+3K122236Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy AfterloaderVarian Medical Systems, Inc.201201
+4K213942EsteyaNucletron B.V.20220—
+4K182641Sensus IORT SystemSensus Healthcare, Inc.20190—
+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—