510(k) Report

Devices descending from DEN230003

16 later devices reach Viz HCM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260332EchoNextPathwai, Inc.20260—
+1K250507Hypertension Notification Feature (HTNF)Apple, Inc.20250—
+1K233549Tempus ECG-AFTempus AI, Inc.20240—
+1K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.20238—
+1K232686CorVista® SystemCorvista Health, Inc.20233—
+2K250649Bunkerhill ECG-EFBunkerHill Health20250—
+2K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.20254—
+2K250119Tempus ECG-Low EFTempus AI, Inc.20250—
+2K233666CorVista System with PH Add-OnAnalytics For Life, Inc.20242—
+2K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.20240—
+3K254302ECG Analysis Software (AiTiALVSD)Medical AI Co., Ltd.20260—
+3K253699Tempus ECG-PHTempus AI, Inc.20260—
+3K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.20260—
+3K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.20260—
+3K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc.20261—
+4K254297Tempus ECG-MRTempus AI, Inc.20260—