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FDA-cleared K201992

Caption Guidance

Caption Health

Authorized purpose: Caption Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images. It is indicated for adult two-dimensional transthoracic echocardiography and acquisition of the specified parasternal, apical, and subcostal standard views.

Modality
Ultrasound
Anatomy
Adult heart; standard 2D transthoracic echocardiography views
Decision
2020-09-18
FDA-cleared K200621

Caption Interpretation Automated Ejection Fraction Software

Caption Health

Authorized purpose: Caption Interpretation Automated Ejection Fraction Software processes previously acquired adult transthoracic cardiac ultrasound images, stores and manipulates images, and measures them using an ultrasound device, personal computer, or compatible DICOM-compliant PACS to provide an automated estimate of left-ventricular ejection fraction that may assist a clinician in cardiac evaluation.

Modality
Ultrasound
Anatomy
Heart; left ventricle; adult cardiac evaluation
Decision
2020-07-22
FDA-cleared K200755

Caption Guidance

Caption Health

Authorized purpose: Caption Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images. It is indicated for adult two-dimensional transthoracic echocardiography and acquisition of the specified parasternal, apical, and subcostal standard views.

Modality
Ultrasound
Anatomy
Adult heart; standard 2D transthoracic echocardiography views
Decision
2020-04-16