510(k) Report

Devices descending from K070831

25 later devices reach Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+1K111660Xelis CardiacInfinitt Co., Ltd.20110—
+1K111613Xelis FusionInfinitt Co., Ltd.20110—
+1K103130Xelis 3DInfinitt Co., Ltd.20110—
+1K111638Impax Volume ViewingAgfa Healthcare N.V.20114—
+1K110077NeucoloncareNeusoft Medical Systems Co., Ltd.20110—
+1K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+1K083691BonevueMicromri, Inc.20090—
+2K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+2K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+2K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+2K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+3K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+3K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+3K151988Visible Patient SuiteVisible Patient, Sas20154—
+3K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+4K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+4K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+5K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+5K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+5K233457RUSHutom, Inc.20240—
+6K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+6K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—