510(k) Report

Devices descending from K130542

9 later devices reach Synapse 3D Lung and Abdomen Analysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223556DeepCatchMedical IP Co., Ltd.20231—
+1K181892Ziostation2Ziosoft, Inc.20181—
+1K151988Visible Patient SuiteVisible Patient, Sas20154—
+2K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+2K212896Visible Patient SuiteVisible Patient, Sas20213—
+2K200315Ziostation2Ziosoft, Inc.20200—
+3K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+3K233457RUSHutom, Inc.20240—
+4K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—