510(k) Report

Devices descending from K083227

49 later devices reach Vida Pulmonary Workstation 2 (PW2) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200990VIDAvisionVida Diagnostics, Inc.20202—
+1K191550BroncholabFluidda, Inc.20200—
+1K173821LungQ SoftwareThirona Corporation20183—
+1K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc.201510—
+1K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+1K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+1K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc.20139—
+1K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.20139—
+1K121449DirectpathCybernet Systems Co., Ltd.20120—
+1K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc.201210—
+1K103480Thoracic VcarGe Medical Systems, LLC20114—
+1K093810BF-NaviKgt, Inc.20101—
+2K233875Brainomix 360 e-LungBrainomix Limited20241—
+2K232412LungQ v3.0.0Thirona BV20241—
+2K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited20231—
+2K223556DeepCatchMedical IP Co., Ltd.20231—
+2K223071Xenoview VDPPolarean, Inc.20220—
+2K203783ClariPulmoClaripi, Inc.20220—
+2K220450syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20221—
+2K212494Lung Image AnalysisPulmonx Corporation20210—
+2K193293XV Lung Ventilation Analysis Software4Dx Limited20200—
+2K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+2K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS20190—
+2K171199AVIEWCoreline Soft Co., Ltd.20186—
+2K181892Ziostation2Ziosoft, Inc.20181—
+2K151988Visible Patient SuiteVisible Patient, Sas20154—
+2K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation20150—
+3K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+3K250766LungQ 4Thirona BV20250—
+3K251484CT:VQ4Dmedical Limited20250—
+3K242411Brainomix 360 e-LungBrainomix Limited20250—
+3K232136syngo.CT ApplicationsSiemens Medical Solutions USA, Inc.20240—
+3K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+3K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+3K212896Visible Patient SuiteVisible Patient, Sas20213—
+3K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+3K200714AVIEWCoreline Soft Co., Ltd.20205—
+3K200315Ziostation2Ziosoft, Inc.20200—
+4K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+4K233457RUSHutom, Inc.20240—
+4K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+4K214036AVIEWCoreline Soft Co., Ltd.20224—
+4K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K243689AVIEWCoreline Soft Co., Ltd.20250—
+5K233211Aview CacCoreline Soft Co., Ltd.20242—
+5K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+6K243696Aview CacCoreline Soft Co., Ltd.20250—