TOMTEC-ARENA

K201632

TOMTEC Imaging Systems GmbH · cleared 2020-08-14 · product code LLZ · Radiology

FDA 510(k) summary for TOMTEC-ARENA (K201632)

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
2
Cited predicates
2
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“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 physicians in the diagnosis.”
Algorithmmachine learning algorithms
source quote (p.7)
“3D surface model is created automatically using machine learning algorithms without user interaction.”
Adaptive (vs locked)No
source quote (p.7)
“3D surface model is created automatically using machine learning algorithms without user interaction.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: safe and effective performance; meets all design and performance requirements

standards: IEC 62304

Bench

sample size not stated

endpoints: safe and effective for the intended users, uses, and use environments

standards: FDA's Guidance for Industry and FDA Staff “Applying Human Factors and Usability Engineering to Medical Devices", 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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
37
drift signals on this device
  • predicate_cohort_contagion

    K201632 shares predicate K150122 with K191171 (EchoGo Core), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K150122 sibling:K191171

  • predicate_cohort_contagion

    K201632 shares predicate K150122 with K191647 (QLAB Advanced Quantification Software), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K150122 sibling:K191647

  • predicate_cohort_contagion

    K201632 shares predicate K150122 with K200974 (QLAB Advanced Quantification Software), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K150122 sibling:K200974

  • predicate_cohort_contagion

    K201632 shares predicate K150122 with K213275 (EchoGo Core (2.0)), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K150122 sibling:K213275

  • predicate_cohort_contagion

    K201632 shares predicate K200974 with K211597 (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 2026-07-22 · predicate:K200974 sibling:K211597

  • predicate_cohort_contagion

    K201632 shares predicate K200974 with K240980 (EPIQ Series Diagnostic Ultrasound System), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-22 · predicate:K200974 sibling:K240980

  • …and 31 more.

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 2026-09-02.

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

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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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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K201632