# K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Nov 25, 2013 after 104 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: 13 generations back to K935595 (1995). 110 ancestors in all.
78 later devices descend from it; 3 cite it directly.
0 of 189 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 1.
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0, Tomtec Imaging Systems GmbH (2009) Summary page 1.
- K103782: 4D MV-Assessment 2.0, Tomtec Imaging Systems GmbH (2011) Summary page 1.
- K110595: 4D Sono-Scan 1.0, Tomtec Imaging Systems GmbH (2011) Summary page 1.
- K110667: Image-Arena and Image-Arena Applications, Tomtec Imaging Systems GmbH (2011) Summary page 1.
- K110746: 4D LV-Analysis 3.0, Tomtec Imaging Systems GmbH (2011) Summary page 1.
- K120135: 2D Cardiac Performance Analysis MR 1.0, Tomtec Imaging Systems GmbH (2012) Summary page 1.
- K122289: Image-Com 5.0, Tomtec Imaging Systems GmbH (2012) Summary page 1.

## Most influential descendants
- 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
- K200232: LVivo Software Application (2020), 19 descendants of its own
- K181685: Vivid E80, Vivid E90, Vivid E95 (2018), 13 descendants of its own

## Indications for use
Indications for use of Tom-fec-Arena software are diagnostic review, quantification and reporting of cardiovascular, fetal and abdominal structures and function of patients with suspected disease.

Source page: https://510kreport.com/device/K132544
Methodology: https://510kreport.com/methodology