# K071232: Image-Arena Applications and Research-Arena Applications

- Pathway: 510(k) (Special)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Jun 20, 2007 after 48 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: 5 generations back to K935595 (1995). 17 ancestors in all.
94 later devices descend from it; 8 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040546: Image-Arena and Research-Arena Applications, Tomtec Imaging Systems GmbH (2004) Summary page 2.

## Most influential descendants
- K083348: Image-Arena Applications (2008), 89 descendants of its own
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), 86 descendants of its own
- K120135: 2D Cardiac Performance Analysis MR 1.0 (2012), 82 descendants of its own
- K082596: Ultraextend Usws-900A (2008), 82 descendants of its own
- K110746: 4D LV-Analysis 3.0 (2011), 80 descendants of its own

## Indications for use
The Image-Arena and Research-Arena Platform Software is intended to serve as a data management platform for clinical application packages. As the Image-Arena and Research-Arena Applications software tool package is modular structured, the clinical applications packages are indicated as software packages for analysis of the left ventricle in heart failure patients, to analyze pathologies related to the Mitral Valve and for analysis of the right ventricle in all patients with a need of right heart function diagnosis.

Source page: https://510kreport.com/device/K071232
Methodology: https://510kreport.com/methodology