# K220956: Libby Echo:Prio

- Pathway: 510(k) (Traditional)
- Applicant: Dyad Medical, Inc.
- Decided: Jul 20, 2022 after 110 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- 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.
1 later device descends from it; 1 cites it directly.
0 of 53 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
- K241430: EchoMeasure (2024), 0 descendants of its own

## Indications for use
Libby™ Echo:Prio is software that is used to process previously acquired DICOM-compliant cardiac ultrasound images, and to make measurements on these images in order to provide automated estimation of several cardiac measurements. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Libby™ Echo:Prio is indicated for use in adult patients.

Source page: https://510kreport.com/device/K220956
Methodology: https://510kreport.com/methodology