# K240769: LVivo IQS

- Pathway: 510(k) (Special)
- Applicant: Dia Imaging Analysis, Ltd.
- Decided: May 24, 2024 after 64 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.
No later device cites it as a predicate yet.
0 of 115 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 4.

## 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/K240769
Methodology: https://510kreport.com/methodology