# K250670: EchoConfidence (USA)

- Pathway: 510(k) (Abbreviated)
- Applicant: Mycardium AI Limited
- Decided: Jun 30, 2025 after 117 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: 16 generations back to K935595 (1995). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 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 5.
- K191171: EchoGo Core, Ultromics, Ltd. (2019) Summary page 5.

## Indications for use
EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. The intended medical indication is for patients requiring review or analysis of their echocardiographic images acquired for their cardiac anatomy, structure and function. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments. The intended patient population is both healthy individuals and patients in whom an underlying cardiac disease is known or suspected; the intended patient age range is for adults (>= 22 years old) and adolescent in the age range 18 – 21 years old.

Source page: https://510kreport.com/device/K250670
Methodology: https://510kreport.com/methodology