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FDA 510(k)

EchoMD Automated Ejection Fraction Software

K-Number: K173780 · 2018-06-14

ApplicantBay Labs, Inc.
Decision Date2018-06-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoMD Automated Ejection Fraction Software is a medical device manufactured by Bay Labs, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K173780. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoMD Automated Ejection Fraction Software?

EchoMD Automated Ejection Fraction Software is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Bay Labs, Inc.. The 510(k) number is K173780.

When was EchoMD Automated Ejection Fraction Software approved by the FDA?

EchoMD Automated Ejection Fraction Software received FDA 510(k) clearance on 2018-06-14, under approval number K173780.

What company makes EchoMD Automated Ejection Fraction Software?

EchoMD Automated Ejection Fraction Software is manufactured by Bay Labs, Inc..

What is the FDA product code for EchoMD Automated Ejection Fraction Software?

The FDA product code for EchoMD Automated Ejection Fraction Software is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40714034 Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry. American heart journal (2026)

Other Devices by Bay Labs, Inc.

DEN190040Caption Guidance

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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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