# K130779: Lvivo EF System

- Pathway: 510(k) (Traditional)
- Applicant: Diacardio, Ltd.
- Decided: Aug 15, 2013 after 147 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 11 generations back to K935595 (1995). 49 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072090: Siemens Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.
- K070792: Qlab Quantification, Philips Ultrasound, Inc. (2007) Summary page 1.

## Most influential descendants
- K180995: Vscan Extend (2018), 10 descendants of its own
- K173780: EchoMD Automated Ejection Fraction Software (2018), 10 descendants of its own
- K210791: Us2.v1 (2021), 3 descendants of its own
- K202035: Vscan Air (2020), 3 descendants of its own
- K200621: Caption Interpretation Automated Ejection Fraction Software (2020), 3 descendants of its own

## Indications for use
DiaCardio's LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.

Source page: https://510kreport.com/device/K130779
Methodology: https://510kreport.com/methodology