# K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: May 22, 2009 after 88 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935595 (1995). 64 ancestors in all.
86 later devices descend from it; 4 cite it directly.
0 of 151 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 1.
- K072090: Siemens Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.

## Most influential descendants
- 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
- K103782: 4D MV-Assessment 2.0 (2011), 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

## Recalls of this device
- Jul 30, 2012 · Class II · Z-2463-2012: A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name a

## 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-Com 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-Corn software is intended for reviewing, measuring and reporting of DICOM dBta of thi batdiab rodadlities-US and XA. -It can be' driven by Image;Arena or other third party platforms and is intended to launch other clinical applications. The clinical application package 2D Cardiac Performance Analysis is indicated for cardiac quantification based on echocardiographic data. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagnosis purposes of patients with suspected heart disease.

Source page: https://510kreport.com/device/K090461
Methodology: https://510kreport.com/methodology