ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm

GUDID 00860007426445

Anumana, Inc.

Cardiac electrophysiology processing software

• Primary Device ID: 00860007426445
• NIH Device Record Key: f1264d83-1979-4fb5-91a3-5a2653d89e27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm
• Version Model Number: v 2.3.0 (1010)
• Company DUNS: 118190277
• Company Name: Anumana, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007426407 [Previous]
GS1	00860007426445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232699

FDA Product Code

• QYE: Reduced Ejection Fraction Machine Learning-Based Notification Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

Devices Manufactured by Anumana, Inc.

• 00860007426445 - ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm: 2024-12-13
• 00860007426445 - ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm: 2024-12-13
• 00860007426407 - ECG-AI LEF: 2024-01-23 The Low Ejection Fraction AI-ECG Algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-bas