Radiology AI Directory

FDA-cleared profile

syngo.CT CaScoring

Siemens Medical Solutions USA, Inc.

Authorized purpose: Evaluates and documents calcified coronary lesions from cardiac CT and calculates coronary calcium scores.

Cardiac imaging
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: Evaluates and documents calcified coronary lesions from cardiac CT and calculates coronary calcium scores.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Evaluates and documents calcified coronary lesions from cardiac CT and calculates coronary calcium scores.

Evidence takeaway

Evidence from the reviewed source record: FDA reports integration/functional testing and a bench evaluation of the retrained algorithm; all prespecified criteria passed, with no clinical sample or sensitivity/specificity reported.

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
Evaluates and documents calcified coronary lesions from cardiac CT and calculates coronary calcium scores.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.

Intended users
Physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

FDA intended-user statement.

Care setting and population
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Confirm the intended care setting, patient population, and service line.

Workflow role
Measurement or quantification
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Non-contrast cardiac CT from standard or low-dose spiral/sequential, ECG-gated/triggered acquisitions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

FDA input and acquisition scope.

Output and human action
Marked calcified lesions, assignment to RCA/LM/LAD/LCX, Agatston-equivalent/mass/volume scores per artery and in total, and a paper report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

FDA output description.

Limitations
Stated scope is non-contrast cardiac CT and coronary calcium scoring; no separate FDA limitation/contraindication section or clinical-outcome boundary was identified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

FDA scope is stated; additional limitations remain unknown.

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
K221219
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

FDA specifies CT; normalized to the controlled CT/CTA catalog enum.

Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

FDA body-part row states Heart/Chest and the use is coronary arteries.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-05-17
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

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

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for syngo.CT CaScoring; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
Source

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
FDA reports integration/functional testing and a bench evaluation of the retrained algorithm; all prespecified criteria passed, with no clinical sample or sensitivity/specificity reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Submission-reported FDA evidence summary.

Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

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.

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K221219 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

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 K221219. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
21Fields reviewed
10Source 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, fda decision summary packet, 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. FDA K221219: syngo.CT CaScoring

    U.S. Food and Drug Administration - Published 2022-05-17 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. syngo.CT CaScoring model card (K221219)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, output, limitations, anatomy, implementationCapabilities

  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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K221219

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

    Scope: postmarketSafety

Research history

  1. K221219 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K253786

syngo.CT Coronary Cockpit

Siemens Medical Solutions USA, Inc.

An extension for syngo.via that assists trained physicians with automated and semi-automated analysis, visualization and reporting of cardiac CT angiography volume datasets for...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2026-06-25
Cardiac imaging
FDA-cleared K260169

AV Cardiac CT

Philips Medical Systems Nederland B.V.

AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2026-03-05
Cardiac imaging
FDA-cleared K252217

CT VScore+

Canon Medical Informatics, Inc.

CT VScore+ evaluates calcified coronary lesions on ECG-gated, non-contrast cardiac CT in patients aged 30 years or older, automatically generating coronary calcium scores and...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-11-28
Cardiac imagingQuantification and segmentation