510(k) Report

Devices descending from K983341

42 later devices reach Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132889Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded Applicator Set (4…Nucletron B.V.201401
+1K091154Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring…Nucletron Corporation20094—
+1K082530Applicators for Afterloading BrachytherapyIsodose Control B.V.20080—
+1K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.20049—
+1K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200234—
+2K201272GenevaNucletron B.V.202011
+2K180069HDR MRI Lumen MarkerC4 Imaging, LLC20180—
+2K161688Advanced Gynecological ApplicatorNucletron B.V.201701
+2K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+2K081179Mammosite Cavity Evaluation DeviceHologic, Inc.20082—
+2K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058—
+2K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc.20051—
+2K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…Proxima Therapeutics, Inc.200417—
+2K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200333—
+3K250289Intracavitary/Interstitial SystemVarian Medical Systems20250—
+3K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+3K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+3K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+3K103215Cianna S1, Single Lumen Balloon Applicator KitCianna Medical20100—
+3K101411Savi Preparation DeviceCianna Medical, Inc.20100—
+3K092405Mammosite Multi LumenHologic, Inc.20090—
+3K092323Contura Cavity Maintenance CatheterSenorx, Inc.20091—
+3K090914Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc.20091—
+3K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+3K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc.200811—
+3K072683Axxent Electronic Brachytherapy SystemXoft, Inc.20085—
+3K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc.200714—
+3K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC20060—
+4K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.20190—
+4K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+4K132097Best Multi-Lumen Balloon Applicator for BrachytherapyBest Medical International, Inc.20130—
+4K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.20134—
+4K082264Contura Lumen MarkerSenorx, Inc.20080—
+4K080791Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and…Senorx, Inc.20080—
+5K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+5K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.20161—
+5K132092EsteyaNucletron B.V.20131—
+6K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+6K213942EsteyaNucletron B.V.20220—
+6K182641Sensus IORT SystemSensus Healthcare, Inc.20190—
+6K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+6K180308PreludeMedcom GmbH20180—