510(k) Report

Devices descending from K083446

29 later devices reach Cardiac Function Analysis, Calcium Scoring through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151212Ziostation2Qi Imaging, LLC20152—
+1K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+2K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+2K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+2K203256Imbio RV/LV SoftwareImbio, LLC202117—
+2K181892Ziostation2Ziosoft, Inc.20181—
+3K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+3K243038Salix CentralArtrya Limited20251—
+3K241922MyomicsPhantomics, Inc.20250—
+3K2420621CMR ProMycardium AI Limited20240—
+3K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+3K240786AutoChamberHeartLung Corporation20241—
+3K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+3K223396Rapid RV/LVIschemaview, Inc.20231—
+3K221100Viz RV/LVViz. Ai, Inc.20224—
+3K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+3K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+3K200315Ziostation2Ziosoft, Inc.20200—
+4K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+4K252029AI-CVDHeartLung Corporation20250—
+4K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+4K243378Rapid MLSIschemaview, Inc.20250—
+4K232613CT CardiomegalyInnolitics, LLC20241—
+4K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+4K231149qXR-CTRQure.Ai Technologies20230—
+5K243859PRAEVAorta®2Nurea20250—
+5K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+5K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+6K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—