510(k) Report

Devices descending from K072821

17 later devices reach Vitrea 4DCT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132853NovapacsNovarad Corp.201462
+1K121213VitreaadvancedVital Images, Inc.201281
+1K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+2K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+2K160371NovaPACSNovarad Corporation20165—
+2K153289HealthmyneHealthmyne, Inc.20160—
+2K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+3K171754NovaPACSNovarad Corporation201741
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K231662Aid-UIaid20241—
+4K221796Cyware 4H and Cysart 4HAbys Medical20221—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K250039HPACSHealthhub20250—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K243069Lumys (V1)Intradys20250—
+5K233457RUSHutom, Inc.20240—
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—