FDA-cleared profile
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.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Current vendor materials are product-family evidence for K201632; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K201632; confirm the exact cleared version, enabled options, deployment, and local compatibility.
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.
Current vendor materials are product-family evidence for K201632; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K201632 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.
product family · checked 2026-09-03Test 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.
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 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
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 2026-09-03Revalidate 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.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
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.
Manufacturer software, quantification, reporting, data-transfer, and compatibility verification and validation · Cardiovascular, fetal, and abdominal ultrasound quantification and reporting workflows
exact submission · Tested version: TOMTEC-ARENA · Sponsor or vendor studyK201632
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related Ultrasound workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established40956275
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related Ultrasound workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established32007947
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related Ultrasound workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established33389361
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related Ultrasound workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not establishedNCT05451277
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Heart/Cardiovascular or related Ultrasound workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not establishedNCT04313296
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
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
Sources accessed through 2026-09-03.
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