# K083348: Image-Arena Applications

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Dec 23, 2008 after 40 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). 28 ancestors in all.
89 later devices descend from it; 2 cite it directly.
0 of 118 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.
- K061995: Xcelera, Philips Medical Systems North America Co. (2006) Summary page 2.

## Most influential descendants
- 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
- K110746: 4D LV-Analysis 3.0 (2011), 80 descendants of its own
- K110667: Image-Arena and Image-Arena Applications (2011), 80 descendants of its own
- K122289: Image-Com 5.0 (2012), 79 descendants of its own

## Indications for use
The Image-Arena Platform Software is intended to serve as a data management platform for clinical application packages. It provides information that is used for clinical diagnosis purposes. The software is suited for stand-alone workstations as well as for networked multi-system installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology. As the Image-Arena Applications software tool package is modular structured, clinical applications packages with different indications for use can be connected. Echo-Corn software is intended to serve as a versatile solution for Stress Echo examinations in patients who may not be receiving enough blood or oxygen because of blocked arteries Image-Coin software is intended for reviewing, measuring and reporting of DICOM data of the cardiac modalities US and XA. It can be driven by Image-Arena or other third party platforms and is intended to launch other clinical applications.

Source page: https://510kreport.com/device/K083348
Methodology: https://510kreport.com/methodology