Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Authorized purpose: Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Heart/Coronary Arteries Input: Non-contrast CT heart calcium-score studies from adults aged 30 and older, with GE or Siemens equipment or subsidiaries recommended; exclusions include cardiac devices/electrodes, established ischemic disease, and thoracic metallic devices.
- Who uses it? Intended users: Trained healthcare professionals responsible for patient-management decisions under standard of care.
- What does the software produce? Output: DICOM result files containing an automatic 3D coronary-calcification mask, vessel classification for LM/LAD/LCX/RCA, and Agatston category classification for downstream scoring; the device does not output the Agatston score directly or alter the original data.
- What is its most important limitation? Key limitation: Excluded patients include pre-existing cardiac devices/electrodes, established ischemic disease such as grafts, stents, or PTCA, and thoracic metallic devices. Use with GE or Siemens equipment or subsidiaries is recommended; other manufacturers are not recommended. The packet is internally inconsistent about gated status in a comparison paragraph, so gated support is not inferred beyond the non-contrast CT-heart indication.
Clinical takeaway
Clinical role: Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
Evidence takeaway
Evidence from the reviewed source record: FDA retrospective cohort study included 422 adults aged 30 and older with non-contrast calcium-score CT and heart coverage; ground truth used three annotators and majority voting, with at least 50% of ground-truth data from multiple U.S. locations. FDA testing used segmentation Dice, Agatston-category accuracy, vessel-classification Dice, precision/recall, and agreement analyses. The packet states acceptance criteria of at least 80% accuracy/Dice with a 95% CI lower bound at least 75%, and reports mean Agatston-category accuracies exceeding 94% with lower bounds above 75%; it also reports no specific site count.
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
- Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
- Intended users
- Trained healthcare professionals responsible for patient-management decisions under standard of care.
- Care setting and population
- Clinical use of adult calcium-score CT studies in medical imaging workflows.
- Workflow role
- Segmentation and classification support for downstream calcium scoring; adjunctive information only and not a stand-alone diagnostic tool.
- Required input
- Non-contrast CT heart calcium-score studies from adults aged 30 and older, with GE or Siemens equipment or subsidiaries recommended; exclusions include cardiac devices/electrodes, established ischemic disease, and thoracic metallic devices.
- Output and human action
- DICOM result files containing an automatic 3D coronary-calcification mask, vessel classification for LM/LAD/LCX/RCA, and Agatston category classification for downstream scoring; the device does not output the Agatston score directly or alter the original data.
- Limitations
- Excluded patients include pre-existing cardiac devices/electrodes, established ischemic disease such as grafts, stents, or PTCA, and thoracic metallic devices. Use with GE or Siemens equipment or subsidiaries is recommended; other manufacturers are not recommended. The packet is internally inconsistent about gated status in a comparison paragraph, so gated support is not inferred beyond the non-contrast CT-heart indication.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Containerized application on off-the-shelf hardware or a cloud platform; DICOM result files are viewable in DICOM-compliant systems and may be used by external viewers. Exact interfaces, versions, and current deployment configuration are not established.
- Deployment and data flow
- Hybrid
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for TeraRecon Cardiovascular.Calcification.CT; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- FDA retrospective cohort study included 422 adults aged 30 and older with non-contrast calcium-score CT and heart coverage; ground truth used three annotators and majority voting, with at least 50% of ground-truth data from multiple U.S. locations. FDA testing used segmentation Dice, Agatston-category accuracy, vessel-classification Dice, precision/recall, and agreement analyses. The packet states acceptance criteria of at least 80% accuracy/Dice with a 95% CI lower bound at least 75%, and reports mean Agatston-category accuracies exceeding 94% with lower bounds above 75%; it also reports no specific site count.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
TeraRecon Cardiovascular.Calcification.CT regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K250288
- Samplen=422
- IndependenceIndependence not established
K250288
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
- Vendor documentation pending
No public price or quote for the exact K250288 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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 exact-identifier FDA recall query returned no native recall record for K250288. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K250288 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
24Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, 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
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FDA K250288: TeraRecon Cardiovascular.Calcification.CT
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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TeraRecon Cardiovascular.Calcification.CT model card (K250288)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K250288
Scope: postmarketSafety
Research history
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K250288 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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