510(k) Report

Devices descending from K090504

10 later devices reach CSBP-001A Body Perfusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251484CT:VQ4Dmedical Limited20250—
+1K121213VitreaadvancedVital Images, Inc.201281
+2K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+2K153289HealthmyneHealthmyne, Inc.20160—
+2K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K233457RUSHutom, Inc.20240—
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—