# K200232: LVivo Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Dia Imaging Analysis, Ltd.
- Decided: Jun 23, 2020 after 145 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: 14 generations back to K935595 (1995). 111 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena, Tomtec Imaging Systems GmbH (2013) Summary page 4.

## Most influential descendants
- K210053: LVivo Software Application (2021), 11 descendants of its own
- K222970: LVivo IQS (2023), 6 descendants of its own
- K222406: Clarius AI (2023), 3 descendants of its own
- K240553: LVivo Software Application (2024), 2 descendants of its own
- K202546: LVivo Seamless (2020), 2 descendants of its own

## Indications for use
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.

Source page: https://510kreport.com/device/K200232
Methodology: https://510kreport.com/methodology