# K140153: Ventripoint Medical System

- Pathway: 510(k) (Traditional)
- Applicant: Ventripoint, Inc.
- Decided: Mar 6, 2014 after 43 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: 10 generations back to K935595 (1995). 27 ancestors in all.
2 later devices descend 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)
- K102017: SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.
- K963807: Tomtec Echo-Scan, Tomtec Imaging Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K150628: VentriPoint Medical System (2015), 1 descendant of its own
- 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 used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.

Source page: https://510kreport.com/device/K140153
Methodology: https://510kreport.com/methodology