# K213544: Tomtec-Arena

- Pathway: 510(k) (Traditional)
- Applicant: Tomtec Imaging Systems GmbH
- Decided: Jan 6, 2022 after 59 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 19 generations back to K935595 (1995). 146 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201632: Tomtec-Arena, Tomtec Imaging Systems GmbH (2020) Summary page 6.

## Most influential descendants
- K230209: Sonix Health (2023), 3 descendants of its own
- K243684: BrightHeart View Classifier (2025), 1 descendant of its own
- K250330: 3mensio Workstation (2025), 0 descendants of its own
- K251456: BrightHeart View Classifier (2025), 0 descendants of its own
- K241659: Ultrasound Workspace (UWS 6.0) (2025), 0 descendants of its own

## 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 physician in the diagnosis.

Source page: https://510kreport.com/device/K213544
Methodology: https://510kreport.com/methodology