Regulatory Approvals and Labeling - UltraSight

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 4. South Korea / KFDA	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.
USFDA/Multi-device	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). This clearance allows health systems to deploy UltraSight™ technology across existing ultrasound fleets. With real-time AI-assisted image acquisition, including a quality meter and automatic guidance to the optimal view, UltraSight™ technology supports reliable, repeatable FoCUS across care settings and helps reduce variability at the point of care.
USFDA/PVAD-IQ	UltraSight received FDA clearance for its PVAD IQ software on February 25, 2026, a machine learning tool designed to analyze ultrasound images and monitor the positioning of percutaneous ventricular assist devices (PVADs) in patients over 18. The software aims to improve the consistency and speed of cardiac imaging in ICU environments Purpose: To assist clinicians in validating the position of microaxial flow pumps (like Impella) using echocardiography to optimize patient care. Technology: AI-based Software as a Medical Device (SaMD) that analyzes ultrasound clips to measure the location of the aortic valve plane and the pump inlet.