# K253535: Ligence Heart

- Pathway: 510(k) (Traditional)
- Applicant: Ligence Uab
- Decided: Feb 27, 2026 after 106 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or sonographers for clinical decision making. Ligence Heart is indicated for use in adult patients. Ligence Heart has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g., tumors, thrombi). 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, or use of suboptimal settings (e.g., gain, contrast, depth) may lead to lower accuracy of the software. • Ligence Heart has not been validated in patients with prosthetic or surgically altered cardiac valves, implantable intracardiac devices, or irregular (non-sinus) rhythm; these conditions may affect automated measurement accuracy.

Source page: https://510kreport.com/device/K253535
Methodology: https://510kreport.com/methodology