# K040546: Image-Arena and Research-Arena Applications

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Apr 27, 2004 after 56 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: 4 generations back to K935595 (1995). 16 ancestors in all.
184 later devices descend from it; 5 cite it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022824: Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical View 1.X, Tomtec Imaging Systems GmbH (2002) Summary page 2.
- K001592: Echocom, Imagecom, Dokucom, Tomtec Imaging Systems GmbH (2000) Summary page 2.
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 2.
- K032114: Sequoia 8.0 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.

## Most influential descendants
- K060992: Syngo US Workplace (2006), 97 descendants of its own
- K091286: Syngo US Workplace (2009), 95 descendants of its own
- K071232: Image-Arena Applications and Research-Arena Applications (2007), 94 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own

## Indications for use
The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies. The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering. The software is suited to stand-alone workstations as well as networked multi-system installations and is therefore 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, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.

Source page: https://510kreport.com/device/K040546
Methodology: https://510kreport.com/methodology