# K240553: LVivo Software Application

- Pathway: 510(k) (Special)
- Applicant: Dia Imaging Analysis, Ltd.
- Decided: Oct 4, 2024 after 219 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: 17 generations back to K935595 (1995). 114 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222970: LVivo IQS, Dia Imaging Analysis, Ltd. (2023) Summary page 5.

## Most influential descendants
- K243862: LVivo Software Application (2025), 0 descendants of its own
- K243235: LVivo Software Application (2025), 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. In addition, it has the ability to provide Quality Score feedback.

Source page: https://510kreport.com/device/K240553
Methodology: https://510kreport.com/methodology