# K243331: LVivo Seamless

- Pathway: 510(k) (Special)
- Applicant: Dia Imaging Analysis, Ltd.
- Decided: Mar 6, 2025 after 133 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)
- K212466: LVivo Seamless, Dia Imaging Analysis, Ltd. (2021) 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 of patients and Age >18.

Source page: https://510kreport.com/device/K243331
Methodology: https://510kreport.com/methodology