# DEN220063: Caption Interpretation Automated Ejection Fraction Software

- Pathway: De Novo (Direct)
- Applicant: Caption Health, Inc.
- Decided: Feb 24, 2023 after 149 days
- Product code: QVD (Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan)
- Device class: 2
- Regulation: 21 CFR 892.2055
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.

Source page: https://510kreport.com/device/DEN220063
Methodology: https://510kreport.com/methodology