510(k) Report

Devices descending from K250652

4 later devices reach ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254302ECG Analysis Software (AiTiALVSD)Medical AI Co., Ltd.20260—
+1K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.20260—
+1K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.20261—
+2K254297Tempus ECG-MRTempus AI, Inc.20260—