# K241430: EchoMeasure

- Pathway: 510(k) (Traditional)
- Applicant: Icardio.Ai
- Decided: Oct 10, 2024 after 142 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)
- K220956: Libby Echo:Prio, Dyad Medical, Inc. (2022) Summary page 5.

## Indications for use
iCardio.ai EchoMeasure is software that is used to process previously acquired DICOM-compliant cardiac ultrasound images, and to make measurements on these images in order to provide automated estimation of several cardiac measurements. 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. iCardio.ai EchoMeasure is indicated for use in adult patients.

Source page: https://510kreport.com/device/K241430
Methodology: https://510kreport.com/methodology