# K210053: LVivo Software Application

- Pathway: 510(k) (Special)
- Applicant: Dia Imaging Analysis, Ltd.
- Decided: Feb 5, 2021 after 28 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: 15 generations back to K935595 (1995). 112 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200232: LVivo Software Application, Dia Imaging Analysis, Ltd. (2020) Summary page 4.

## Most influential descendants
- K222970: LVivo IQS (2023), 6 descendants of its own
- K240553: LVivo Software Application (2024), 2 descendants of its own
- K240953: AI Platform 2.0 (AIP002) (2024), 1 descendant of its own
- K232501: AI Platform (AIP001) (2023), 1 descendant of its own
- K260217: AI Platform 2.2 (AIP002) (2026), 0 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/K210053
Methodology: https://510kreport.com/methodology