# K243862: LVivo Software Application

- Pathway: 510(k) (Special)
- Applicant: Dia Imaging Analysis, Ltd.
- Decided: Mar 17, 2025 after 91 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: 18 generations back to K935595 (1995). 115 ancestors in all.
No later device cites it as a predicate yet.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240553: LVivo Software Application, Dia Imaging Analysis, Ltd. (2024) Summary page 5.

## 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 and Age >18. In addition, it has the ability to provide Quality Score feedback.

Source page: https://510kreport.com/device/K243862
Methodology: https://510kreport.com/methodology