# K110667: Image-Arena and Image-Arena Applications

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Apr 8, 2011 after 30 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: 7 generations back to K935595 (1995). 29 ancestors in all.
80 later devices descend from it; 3 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083348: Image-Arena Applications, Tomtec Imaging Systems GmbH (2008) Summary page 2.
- K061995: Xcelera, Philips Medical Systems North America Co. (2006) Summary page 2.

## Most influential descendants
- K122289: Image-Com 5.0 (2012), 79 descendants of its own
- 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

## Indications for use
The Iniage-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities. Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform. The software is suited for stand-alone workstations as well as for networked multi-system installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool. Image-Arena is not intended to be used for reading of mammography images. Image-Corn software is intended for reviewing, and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools. Echo-Corn software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Coin software is intended for reviewing, wall motion scoring and reporting of stress echo studies.

Source page: https://510kreport.com/device/K110667
Methodology: https://510kreport.com/methodology