510(k) Report

Devices descending from K864210

112 later devices reach Microselectron-HDR (High Dose Rate) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222775Aarhus Applicator SetVarian Medical Systems, Inc.20231—
+5K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc.20182—
+5K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+5K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.20161—
+5K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+6K252884Guided Aarhus Applicator SetVarian Medical Systems20250—
+6K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+6K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc.20191—
+6K182641Sensus IORT SystemSensus Healthcare, Inc.20190—
+6K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+6K180308PreludeMedcom GmbH20180—
+7K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc.20220—