510(k) Report

Devices descending from K120361

13 later devices reach Synapse 3D Base Tools through their predicates, nearest generation first.

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