Radiology AI Directory

FDA-cleared profile

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and third-party applications.

Breast imagingCardiac imagingQuantification and segmentationUltrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and third-party applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Qualified imaging professionals and physicians trained for the represented anatomy and workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospital or outpatient imaging analysis and reporting environments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Medical-image processing, measurement, quantification, visualization, and reporting support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Supported DICOM images and release-specific user inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Measurements, segmentations, visualizations, calculations, and reports for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
AI-assisted or semi-automated measurements require professional review and editing. The named release should not be generalized to unrelated TOMTEC modules, third-party image types, or mammography workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K201632
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-08-14
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K201632; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Software on a workstation, server, or supported virtual environment with release-specific licenses.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K201632; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified imaging professionals and physicians trained for the represented anatomy and workflow should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted or semi-automated measurements require professional review and editing. The named release should not be generalized to unrelated TOMTEC modules, third-party image types, or mammography workflows.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K201632; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K201632 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. AI-assisted or semi-automated measurements require professional review and editing. The named release should not be generalized to unrelated TOMTEC modules, third-party image types, or mammography workflows.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted or semi-automated measurements require professional review and editing. The named release should not be generalized to unrelated TOMTEC modules, third-party image types, or mammography workflows.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K201632 reports software, data-transfer, quantification, reporting, and compatibility verification and validation; the FDA summary does not identify a new clinical study. The device is not intended for primary mammography interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K201632 FDA performance package for TOMTEC-ARENA

  • DesignManufacturer software, quantification, reporting, data-transfer, and compatibility verification and validation
  • PopulationCardiovascular, fetal, and abdominal ultrasound quantification and reporting workflows
  • Scopeexact submission
  • Tested versionTOMTEC-ARENA
  • IndependenceSponsor or vendor study

K201632

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K201632 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
25Fields reviewed
12Source classes checked
15Awaiting review PubMed leads
2Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 15 PubMed and 2 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. K201632 FDA decision source

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. TOMTEC-ARENA model card (K201632)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  8. TOMTEC instructions for use library

    TOMTEC Imaging Systems - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

  9. Long-Term Favorable Cardiac Remodeling in Obstructive Hypertrophic Cardiomyopathy Patients Treated With Mavacamten for Up to 128 Weeks: Insights From the VALOR-HCM Trial.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Comparison of strain and dyssynchrony measurements in fetal two-dimensional speckle tracking echocardiography using Philips and TomTec.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Inter-vendor comparison of left atrial strain using layer specific strain analysis.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. Impact of inter-vendor variability on evaluation of left ventricular mechanical dispersion.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Fetal left and right ventricular strain parameters using speckle tracking in congenital heart diseases.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. Characterization of Subclinical Cardiac Dysfunction by Speckle Tracking Echocardiography in Patients With Non-severe Acute-Phase Myocarditis.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Feasibility of Intraoperative 3-Dimensional Speckle-Tracking Echocardiography in Patients Undergoing Surgical Aortic Valve Replacement: A Prospective Observational Pilot Study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  16. Vendor and software based variation in left atrial strain measurements: implications for clinical practice.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  17. Correlation of cavotricuspid isthmus dynamics with clinical parameters: insights from interventional cardiac magnetic resonance imaging.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  18. Correlation between three-dimensional echocardiography and cardiopulmonary fitness in patients with univentricular heart: A cross-sectional multicentre prospective study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  19. Fully Automated Versus Standard Tracking of Left Ventricular Ejection Fraction and Longitudinal Strain: The FAST-EFs Multicenter Study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  20. Reliability of left ventricular global longitudinal strain across acquisition and analysis techniques: a prospective comparative study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  21. Inherited Hypertrabeculation? Genetic and Clinical Insights in Blood Relatives of Genetically Affected Left Ventricular Excessive Trabeculation Patients.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  22. Echocardiographic assessment of myocardial function and mechanics during veno-venous extracorporeal membrane oxygenation.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  23. Intraoperative 3-Dimensional Echocardiography-Derived Right Ventricular Volumetric Analysis in Chronic Thromboembolic Pulmonary Hypertension Patients Before and After Pulmonary Thromboendarterectomy.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  24. At the Heart of the Matter - Speckle Tracking Echocardiography in Lupus Mothers and Their Offspring

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  25. Prediction and Maintenance of Sinus Rhythm Among Atrial Fibrillation Patients

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K201632 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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