510(k) Report

Devices descending from K203256

17 later devices reach Imbio RV/LV Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240786AutoChamberHeartLung Corporation20241—
+1K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+1K223396Rapid RV/LVIschemaview, Inc.20231—
+1K221100Viz RV/LVViz. Ai, Inc.20224—
+1K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+1K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+2K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+2K252029AI-CVDHeartLung Corporation20250—
+2K243378Rapid MLSIschemaview, Inc.20250—
+2K2420621CMR ProMycardium AI Limited20240—
+2K232613CT CardiomegalyInnolitics, LLC20241—
+2K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+2K231149qXR-CTRQure.Ai Technologies20230—
+3K243859PRAEVAorta®2Nurea20250—
+3K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+3K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+4K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—