510(k) Report

Devices descending from K050843

8 later devices reach Axxent Electronic Brachytherapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090914Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067EXoft, Inc.20091—
+1K072683Axxent Electronic Brachytherapy SystemXoft, Inc.20085—
+2K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.20190—
+2K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.20134—
+3K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.20161—
+3K132092EsteyaNucletron B.V.20131—
+4K213942EsteyaNucletron B.V.20220—
+4K182641Sensus IORT SystemSensus Healthcare, Inc.20190—