# K173780: EchoMD Automated Ejection Fraction Software

- Pathway: 510(k) (Traditional)
- Applicant: Bay Labs, Inc.
- Decided: Jun 14, 2018 after 184 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 50 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130779: Lvivo EF System, Diacardio, Ltd. (2013) Summary page 4.

## Most influential descendants
- K210791: Us2.v1 (2021), 3 descendants of its own
- K200621: Caption Interpretation Automated Ejection Fraction Software (2020), 3 descendants of its own
- K210747: Caption Interpretation Automated Ejection Fraction Software (2022), 2 descendants of its own
- K220956: Libby Echo:Prio (2022), 1 descendant of its own
- K253593: Clarius Ejection Fraction AI (2026), 0 descendants of its own

## Indications for use
The Bay Labs, Inc. EchoMD Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The EchoMD Automated Ejection Fraction Software is indicated for use in adult patients.

Source page: https://510kreport.com/device/K173780
Methodology: https://510kreport.com/methodology