# K103782: 4D MV-Assessment 2.0

- Pathway: 510(k) (Special)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Jan 27, 2011 after 31 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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). 65 ancestors in all.
79 later devices descend from it; 1 cites it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071232: Image-Arena Applications and Research-Arena Applications, Tomtec Imaging Systems GmbH (2007) Summary page 1.
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0, Tomtec Imaging Systems GmbH (2009) Summary page 1.

## Most influential descendants
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena (2013), 78 descendants of its own
- K150122: Tomtec-Arena TTA2 (2015), 56 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own
- K173341: Vivid E80, Vivid E90, Vivid E95 (2017), 20 descendants of its own
- K200232: LVivo Software Application (2020), 19 descendants of its own

## Indications for use
MV-Assessment 2.0 is intended as software to analyze pathologies related to the mitral valve.

Source page: https://510kreport.com/device/K103782
Methodology: https://510kreport.com/methodology