Caption Health radiology AI products

FDA-cleared K210747

Caption Interpretation Automated Ejection Fraction Software

Caption Health

The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate...

Modality: Ultrasound
Anatomy: Heart/Cardiovascular
Decision: 2022-01-19

FDA-cleared K201992

Caption Guidance

Caption Health

Caption 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: 2020-09-18

Cardiac imaging Ultrasound workflow

FDA-cleared K200621

Caption Interpretation Automated Ejection Fraction Software

Caption Health

Caption Interpretation Automated Ejection Fraction Software processes previously acquired adult transthoracic cardiac ultrasound images, stores and manipulates images, and...

Modality: Ultrasound
Anatomy: Heart; left ventricle; adult cardiac evaluation
Decision: 2020-07-22

Cardiac imaging Quantification and segmentation Ultrasound workflow

FDA-cleared K200755

Caption Guidance

Caption Health

Caption 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: 2020-04-16

Cardiac imaging Ultrasound workflow