Caption Health, Inc. radiology AI products

FDA-cleared K243065

Cardiac Guidance

Caption Health, Inc.

Cardiac Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images. It is...

Modality: Ultrasound
Anatomy: Adult heart; standard 2D transthoracic echocardiography views
Decision: 2025-01-15

Cardiac imaging Ultrasound workflow

FDA-authorized DEN220063

Caption Interpretation Automated Ejection Fraction Software

Caption Health, Inc

Automated estimation of adult left-ventricular ejection fraction from previously acquired transthoracic echocardiography images to assist clinician cardiac evaluation.

Modality: Ultrasound
Anatomy: Heart/Cardiovascular
Decision: 2023-02-24

Cardiac imaging Ultrasound workflow