TOMTEC-ARENA

K213544

TOMTEC Imaging Systems GmbH · cleared 2022-01-06 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmartificial intelligence and machine learning (AI/ML) algorithm... Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach.
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.”
Adaptive (vs locked)No
source quote (p.5)
“The training process begins with the model observing, learning, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

n=500 cases

Bench

sample size not stated

standards: IEC 62304

Bench

sample size not stated

standards: IEC 62366-1

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213544