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FDA 510(k)

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

K-Number: K253801 · 2026-04-07

ApplicantAnumana, Inc.
Decision Date2026-04-07
Product CodeSHP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is a medical device manufactured by Anumana, Inc.. It received FDA 510(k) clearance on 2026-04-07 under approval number K253801. The device is classified under product code SHP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is a medical device that received FDA 510(k) clearance on 2026-04-07. It is manufactured by Anumana, Inc.. The 510(k) number is K253801.

When was ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) approved by the FDA?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) received FDA 510(k) clearance on 2026-04-07, under approval number K253801.

What company makes ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is manufactured by Anumana, Inc..

What is the FDA product code for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)?

The FDA product code for ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) is SHP.

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Other Devices by Anumana, Inc.

K233160NeuTrace EP Mapping System v.2.1 K232699Low Ejection Fraction AI-ECG Algorithm K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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