TOMTEC-ARENA
K213544TOMTEC Imaging Systems GmbH · cleared 2022-01-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“TOMTEC-ARENA is a clinical software package for reviewing, quantifying and reporting digital medical data. The software can be integrated into third party platforms. The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm.”
source quote (p.5)
“The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm. The AI/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach.”
Validation studies (2)
Retrospective clinical
n=500 cases
Bench
sample size not stated
endpoints: Product Specifications; Design Review; Risk Analysis; Software Verification; Summative Usability Evaluation
standards: IEC 62304 “Medical device software - Software life-cycle processes”, IEC 62366-1 “Medical devices – Part 1: Application of usability engineering to medical devices”
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).