TOMTEC-ARENA
TOMTEC Imaging Systems GmbHTOMTEC-ARENA is medical software designed to help clinicians review and quantify cardiovascular, fetal, and abdominal ultrasound images. It incorporates AI to provide semi-automated measurements, improving workflow efficiency while allowing users to edit or accept these measurements. This supports physicians in diagnosing suspected diseases by providing detailed and accurate imaging analysis.
Intended 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.
Technology
TOMTEC-ARENA is a clinical software package for reviewing, quantifying, and reporting digital medical data. The AI/ML algorithm is a convolutional neural network trained with supervised learning on ~2800 echocardiographic studies to perform semi-automated and editable measurements on BMODE and Doppler ultrasound images, allowing editing and acceptance by users.
Performance
The device underwent design review, risk analysis, software verification per IEC 62304, and usability testing per IEC 62366-1 and FDA guidance. Verification confirmed that the modifications did not compromise safety or effectiveness. No new clinical testing was conducted; equivalence to predicate device established.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/8/2021
1 month - 2
FDA Approval
1/6/2022
Other devices from TOMTEC Imaging Systems GmbH
- TOMTEC-ARENA2020 • 510K
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