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FDA-cleared K243239

Lung AI (LAI001)

Exo Inc

Authorized purpose: Lung AI LAI001 assists trained healthcare professionals performing point-of-care lung ultrasound by detecting and visualizing pleural effusion and consolidation or atelectasis in lung ultrasound cine clips.

Modality
Ultrasound
Anatomy
Lung; pleural effusion and consolidation or atelectasis at the PLAPS point
Decision
2025-04-24
FDA-cleared K242359

Strain AI (SAI001)

Exo Inc

Authorized purpose: Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept or reject measurements.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2024-11-20