TOMTEC-ARENA

K213544

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

FDA 510(k) summary for TOMTEC-ARENA (K213544)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
3
Cited predicates
2
Performance observations
0
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • predicate_cohort_contagion

    K213544 shares predicate K211597 with K233788 (EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K211597 sibling:K233788

  • predicate_cohort_contagion

    K213544 shares predicate K211597 with K242800 (The 5000 Compact Series Ultrasound Systems), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K211597 sibling:K242800

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code QIH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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syngo.CT Coronary Cockpit

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CMN Capillary Function with Oncology Virtual Expert

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cleared 2026-06-22

Synapse PACS (7.6.0)

K261713

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cleared 2026-06-18

MediAI-OA

K253172

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cleared 2026-06-15

AiORTA - Plan v2.0

K254207

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cleared 2026-03-30

SwiftMR

K253775

Airs Medical, Inc.

cleared 2026-03-26

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