# K150122: Tomtec-Arena TTA2

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Feb 13, 2015 after 24 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: 14 generations back to K935595 (1995). 111 ancestors in all.
56 later devices descend from it; 7 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena, Tomtec Imaging Systems GmbH (2013) Summary page 4.
- K110667: Image-Arena and Image-Arena Applications, Tomtec Imaging Systems GmbH (2011) Summary page 4.

## Most influential descendants
- 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
- K181685: Vivid E80, Vivid E90, Vivid E95 (2018), 13 descendants of its own
- K200974: QLAB Advanced Quantification Software (2020), 12 descendants of its own
- K201632: Tomtec-Arena (2020), 10 descendants of its own

## Recalls of this device
- Sep 23, 2019 · Class II · Z-2496-2020: The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might

## Indications for use
Indications for use of TomTec-Arena software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.

Source page: https://510kreport.com/device/K150122
Methodology: https://510kreport.com/methodology