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FDA 510(k)

ECG Analysis Software (AiTiALVSD)

K-Number: K254302 · 2026-09-30

ApplicantMedical AI Co., Ltd.
Decision Date2026-09-30
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG Analysis Software (AiTiALVSD) is the device name listed in this FDA 510(k) record. The listed applicant is Medical AI Co., Ltd.. It received FDA 510(k) clearance on 2026-09-30 under 510(k) number K254302. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG Analysis Software (AiTiALVSD)?

ECG Analysis Software (AiTiALVSD) is a medical device that received FDA 510(k) clearance on 2026-09-30. The listed applicant is Medical AI Co., Ltd.. The 510(k) number is K254302.

When did ECG Analysis Software (AiTiALVSD) receive FDA 510(k) clearance?

ECG Analysis Software (AiTiALVSD) received FDA 510(k) clearance on 2026-09-30, under 510(k) number K254302.

Who is the listed applicant for ECG Analysis Software (AiTiALVSD)?

The FDA 510(k) record lists Medical AI Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Analysis Software (AiTiALVSD)?

The FDA product code for ECG Analysis Software (AiTiALVSD) is QYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250649Bunkerhill ECG-EFBunkerHill HealthK250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.K250119Tempus ECG-Low EFTempus AI, Inc.K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.

Official Source

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

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