# K173810: Ventripoint Medical System Plus (VMS+)

- Pathway: 510(k) (Traditional)
- Applicant: Ventripoint Diagnostics, Ltd.
- Decided: May 14, 2018 after 150 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150628: VentriPoint Medical System, Ventripoint, Inc. (2015) Summary page 4.

## Indications for use
The VMS+ 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+ 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/K173810
Methodology: https://510kreport.com/methodology