# K120135: 2D Cardiac Performance Analysis MR 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Apr 13, 2012 after 87 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 12 generations back to K935595 (1995). 69 ancestors in all.
82 later devices descend from it; 3 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0, Tomtec Imaging Systems GmbH (2009) Summary page 1.
- K100352: Diagnosoft Harp Model 2.06, Diagnosoft, Inc. (2010) 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
The clinical application package 2D Cardiac Performance Analysis MR is indicated for cardiac quantification based on digital magnetic resonance images. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagndsis purposes of patients with suspected heart disease.

Source page: https://510kreport.com/device/K120135
Methodology: https://510kreport.com/methodology