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FDA 510(k)

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

K-Number: K252360 · 2026-03-28

ApplicantAnumana, Inc.
Decision Date2026-03-28
Product CodeSAT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is a medical device manufactured by Anumana, Inc.. It received FDA 510(k) clearance on 2026-03-28 under approval number K252360. The device is classified under product code SAT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is a medical device that received FDA 510(k) clearance on 2026-03-28. It is manufactured by Anumana, Inc.. The 510(k) number is K252360.

When was ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) approved by the FDA?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) received FDA 510(k) clearance on 2026-03-28, under approval number K252360.

What company makes ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is manufactured by Anumana, Inc..

What is the FDA product code for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

The FDA product code for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is SAT.

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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) K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

Related Devices (Code: SAT)

K233666CorVista System with PH Add-OnAnalytics For Life, Inc.

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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