# K241222: Ventripoint Medical System Plus (VMS+) 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Ventripoint Diagnostics, Ltd.
- Decided: Feb 26, 2025 after 301 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: 21 generations back to K935595 (1995). 140 ancestors in all.
No later device cites it as a predicate yet.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191493: Ventripoint Medical System Plus (VMS+) 3.0, Ventripoint Diagnostics, Ltd. (2019) Summary page 5.

## Indications for use
The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

Source page: https://510kreport.com/device/K241222
Methodology: https://510kreport.com/methodology