510(k) Report

Devices descending from K072737

45 later devices reach CSCS-001A Calcium Scoring Package through their predicates, nearest generation first.

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