# K200621: Caption Interpretation Automated Ejection Fraction Software

- Pathway: 510(k) (Traditional)
- Applicant: Caption Health
- Decided: Jul 22, 2020 after 135 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 51 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173780: EchoMD Automated Ejection Fraction Software, Bay Labs, Inc. (2018) Summary page 4.

## Most influential descendants
- K210747: Caption Interpretation Automated Ejection Fraction Software (2022), 2 descendants of its own
- K253593: Clarius Ejection Fraction AI (2026), 0 descendants of its own
- K232331: InVision Precision LVEF (LVEF) (2024), 0 descendants of its own

## Recalls of this device
- May 19, 2021 · Class II · Z-2111-2021: The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality sco

## 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/K200621
Methodology: https://510kreport.com/methodology