Regulatory Approvals and Labeling
Listed below are the jurisdictions where UltraSight’s software is approved and the labeling for each jurisdiction.
| Jurisdiction | Labeling |
| 1. European Union / CE Mark 2. United States / FDA 510(k) Clearance 3. United Kingdom / UKCA Mark | The UltraSight AI Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight AI Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight AI 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). |
| Israel / Israeli AMAR | The UltraSight AI Guidance Software is indicated for assistance in performing cardiac ultrasound scans. |
