# K150628: VentriPoint Medical System

- Pathway: 510(k) (Traditional)
- Applicant: Ventripoint, Inc.
- Decided: May 22, 2015 after 72 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: 11 generations back to K935595 (1995). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140153: Ventripoint Medical System, Ventripoint, Inc. (2014) Summary page 4.

## Most influential descendants
- K173810: Ventripoint Medical System Plus (VMS+) (2018), 0 descendants of its own

## Indications for use
The VMS 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 system is indicated for use where RV volumes and ejection fractions are warranted or desired.

Source page: https://510kreport.com/device/K150628
Methodology: https://510kreport.com/methodology