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FDA 510(k)

Eko Foundation Analysis Software with Transformers (EFAST)

K-Number: K251494 · 2025-08-12

ApplicantEko Health, Inc.
Decision Date2025-08-12
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eko Foundation Analysis Software with Transformers (EFAST) is a medical device manufactured by Eko Health, Inc.. It received FDA 510(k) clearance on 2025-08-12 under approval number K251494. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eko Foundation Analysis Software with Transformers (EFAST)?

Eko Foundation Analysis Software with Transformers (EFAST) is a medical device that received FDA 510(k) clearance on 2025-08-12. It is manufactured by Eko Health, Inc.. The 510(k) number is K251494.

When was Eko Foundation Analysis Software with Transformers (EFAST) approved by the FDA?

Eko Foundation Analysis Software with Transformers (EFAST) received FDA 510(k) clearance on 2025-08-12, under approval number K251494.

What company makes Eko Foundation Analysis Software with Transformers (EFAST)?

Eko Foundation Analysis Software with Transformers (EFAST) is manufactured by Eko Health, Inc..

What is the FDA product code for Eko Foundation Analysis Software with Transformers (EFAST)?

The FDA product code for Eko Foundation Analysis Software with Transformers (EFAST) is DQD.

Related Clinical Trials

NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT06366867 An Open Platform of Serious Games for Cognitive Intervention COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by Eko Health, Inc.

K233609CORE 500 Digital Stethoscope K233409Eko Low Ejection Fraction Tool (ELEFT)

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160023Electronic Stethoscope DS301Imediplus, Inc. K160016Steth IOStratoscientific, Inc. K172296Stethee ProM3Dicine Pty , Ltd. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, 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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