# K233676: Us2.v2

- Pathway: 510(k) (Traditional)
- Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Decided: Apr 1, 2024 after 137 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 14 generations back to K935595 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210791: Us2.v1, Eko.Ai Pte Ltd. D/B/A Us2.Ai (2021) Summary page 4.

## Indications for use
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: - Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. - Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. - If no gender is present, female referenced guideline values will be used for conclusions. - If Body Surface Area (BSA) is not present, indexed values cannot be provided. - During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.

Source page: https://510kreport.com/device/K233676
Methodology: https://510kreport.com/methodology