510(k) Report

Devices descending from K001682

48 later devices reach Vscore with Ekg Signal Gating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C200745—
+1K013146Viatronic V3D Calcium ScoringViatronix, Inc.20011—
+2K172983HealthCCSZebra Medical Vision, Ltd.201814—
+2K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+2K032823Medicheart, Model Release 1Medicsight20030—
+3K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+3K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20193—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+4K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+4K241440HealthCCSngNano-X AI, Ltd.20240—
+4K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+4K230112CAC SoftwareImbio, Inc.20230—
+4K230223iCAC DeviceBunkerhill, Inc.20236—
+4K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+4K203256Imbio RV/LV SoftwareImbio, LLC202117—
+4K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20202—
+4K181892Ziostation2Ziosoft, Inc.20181—
+5K260166Bunkerhill Contrast CACBunkerHill Health20260—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K250662Bunkerhill MACBunkerHill Health20250—
+5K243038Salix CentralArtrya Limited20251—
+5K241922MyomicsPhantomics, Inc.20250—
+5K243229Bunkerhill AVCBunkerHill Health20253—
+5K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+5K2420621CMR ProMycardium AI Limited20240—
+5K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+5K240786AutoChamberHeartLung Corporation20241—
+5K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K223396Rapid RV/LVIschemaview, Inc.20231—
+5K221100Viz RV/LVViz. Ai, Inc.20224—
+5K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+5K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—
+5K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+5K200315Ziostation2Ziosoft, Inc.20200—
+6K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+6K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+6K252029AI-CVDHeartLung Corporation20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K243378Rapid MLSIschemaview, Inc.20250—
+6K232613CT CardiomegalyInnolitics, LLC20241—
+6K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+6K231149qXR-CTRQure.Ai Technologies20230—
+7K243859PRAEVAorta®2Nurea20250—
+7K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+7K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+8K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—