# K082510: Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D LV-Analysis MR 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Oct 1, 2008 after 33 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: 6 generations back to K935595 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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 2.
- K041682: Caas MRV, Pie Medical Imaging BV (2004) Summary page 2.

## Indications for use
The Image-Arena VA Platform software is intended to serve as a data management platform for clinical application packages. As the Image-Arena Applications software tool package is modular structured, the clinical application packages are indicated as software packages for the ventricular analysis of the heart.

Source page: https://510kreport.com/device/K082510
Methodology: https://510kreport.com/methodology