TOMTEC-ARENA
TOMTEC Imaging Systems GmbHTOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.
Intended Use
Quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
Technology
TOMTEC-ARENA is a clinical software package compatible with IMAGE-ARENA and third party platforms that enhances workflow for review, quantification, and reporting of multi-dimensional medical images. It includes optional modules for cardiac and fetal ultrasound analysis such as 4D RV-Function, 4D MV-Assessment, 4D LV-Analysis, AutoStrain, and others, providing semi-automatic segmentation, tracking, and strain analysis with capability to export results, compatible with DICOM standards.
Performance
Device underwent design control, risk analysis, software verification per IEC 62304, and usability evaluations per FDA guidance and IEC 62366-1 standards. Verification confirmed it meets safety and performance requirements with no adverse impact on safety or effectiveness due to modifications. No new clinical testing was conducted as equivalence to predicates was established.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/16/2020
1 month - 2
FDA Approval
8/14/2020
Other devices from TOMTEC Imaging Systems GmbH
- TOMTEC-ARENA2022 • 510K
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