Exo Imaging radiology AI products

FDA-cleared K260217

AI Platform 2.2 (AIP002)

Exo Imaging

Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the...

Modality: Ultrasound
Anatomy: Heart/Cardiovascular; Lung; Abdomen/Pelvis
Decision: 2026-02-24

FDA-cleared K240953

AI Platform 2.0 (AIP002)

Exo Imaging

Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients...

Modality: Ultrasound
Anatomy: Heart and lungs
Decision: 2024-08-05

Cardiac imaging Quantification and segmentation Ultrasound workflow