510(k) Report

Devices descending from K101662

14 later devices reach Synapse 3D Basic Tools through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+2K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+2K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+2K151988Visible Patient SuiteVisible Patient, Sas20154—
+2K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+3K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+3K212896Visible Patient SuiteVisible Patient, Sas20213—
+4K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+4K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+4K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+4K233457RUSHutom, Inc.20240—
+5K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+5K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—