# K243065: Cardiac Guidance

- Pathway: 510(k) (Traditional)
- Applicant: Caption Health, Inc.
- Decided: Jan 15, 2025 after 110 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: 3 generations back to DEN190040 (2020). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201992: Caption Guidance, Caption Health (2020) Summary page 6.

## Indications for use
The Cardiac Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Cardiac Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Cardiac Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, 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 (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

Source page: https://510kreport.com/device/K243065
Methodology: https://510kreport.com/methodology