510(k) Report

Devices descending from K232699

8 later devices reach Low Ejection Fraction AI-ECG Algorithm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250649Bunkerhill ECG-EFBunkerHill Health20250—
+1K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.20254—
+1K250119Tempus ECG-Low EFTempus AI, Inc.20250—
+1K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.20240—
+2K254302ECG Analysis Software (AiTiALVSD)Medical AI Co., Ltd.20260—
+2K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.20260—
+2K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.20261—
+3K254297Tempus ECG-MRTempus AI, Inc.20260—