510(k) Report

Devices descending from K032067

9 later devices reach Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058—
+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—
+3K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.20134—
+4K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.20161—
+4K132092EsteyaNucletron B.V.20131—
+5K213942EsteyaNucletron B.V.20220—
+5K182641Sensus IORT SystemSensus Healthcare, Inc.20190—