# K161382: LVivo Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Diacardio, Ltd.
- Decided: Jul 28, 2016 after 71 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: 12 generations back to K935595 (1995). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 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 4.
- K091286: Syngo US Workplace, Siemens Medical Solutions USA, Inc. (2009) Summary page 4.
- K130779: Lvivo EF System, Diacardio, Ltd. (2013) Summary page 4.

## Indications for use
DiaCardio’s LVivo 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/K161382
Methodology: https://510kreport.com/methodology