# K260780: HeartFocus

- Pathway: 510(k) (Special)
- Applicant: Deski
- Decided: Jun 3, 2026 after 85 days
- Product code: QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence)
- Device class: 2
- Regulation: 21 CFR 892.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN190040 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242807: HeartFocus (V.1.1.1), Deski (2025) Summary page 5.

## Indications for use
The HeartFocus software is intended to assist and guide medical professionals in the acquisition of cardiac ultrasound images. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. Heartfocus guides the acquisition of two-dimensional transthoracic echocardiography (2D-TTE). Specifically, in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (A4C), Apical 5-Chamber (A5C), Apical 2-Chamber (A2C), Apical 3-Chamber (A3C), Subcostal 4-Chamber (SC-4C), and Subcostal Inferior Vena Cava (SC-IVC). HeartFocus software is indicated for use in adult patients who require a cardiac ultrasound exam.

Source page: https://510kreport.com/device/K260780
Methodology: https://510kreport.com/methodology