# K251416: UltraSight Guidance

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasight, Ltd.
- Decided: Dec 17, 2025 after 224 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
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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K201241: Striate+™, Orthocell, Ltd. (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The UltraSight Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Guidance 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/K251416
Methodology: https://510kreport.com/methodology