# K242807: HeartFocus (V.1.1.1)

- Pathway: 510(k) (Traditional)
- Applicant: Deski
- Decided: Apr 4, 2025 after 199 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: 1 generation back to DEN190040 (2020). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190040: Caption Guidance, Bay Labs, Inc. (2020) Summary page 5.

## Most influential descendants
- K260780: HeartFocus (2026), 0 descendants of its own

## 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/K242807
Methodology: https://510kreport.com/methodology