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 coronary-lesion evaluation, documentation, follow-up and treatment planning.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
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 coronary-lesion evaluation, documentation, follow-up and treatment planning.
FDA source Exact FDA submission Checked 2026-09-06
Trained users with appropriate skill, experience and judgment; a physician is responsible for confirming lesion presence or absence and clinical use of results.
FDA source Exact FDA submission Checked 2026-09-06
The product does not replace clinical judgment. Interpolated CT data may cause tissue near or below scanning resolution to appear healthy; outputs require trained-user review.
FDA source Exact FDA submission Checked 2026-09-06
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
K253786
FDA source Exact FDA submission Checked 2026-08-31
Vendor confirmation Exact FDA submission Checked 2026-09-06
The reviewed material does not provide a dated, scoped installed-configuration security assessment.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
The summary requires trained users but does not establish a current vendor training program or site competency process.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
No verified product monitoring service was found. Site acceptance should evaluate coronary tracing review, edits, reporting and failure handling.
Current-family workstation requirements
The syngo.via View&GO VA55 operator manual lists Windows 11 64-bit, an Intel AVX2-capable CPU and at least 16 GB RAM when using syngo.CT Coronary Cockpit.
product family · checked 2026-09-06
VA55 documentation is later family context and does not establish the exact K253786 VC10 configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Technical FDA testing used multi-country cardiac-CTA datasets; reported vessel-tracing results apply to the specified anatomical and image-quality criteria, not to clinical diagnosis or treatment benefit.
FDA source Exact FDA submission Checked 2026-09-06
Reviewed sources checked Exact FDA submission Checked 2026-09-06
No disease-detection specificity was established by the reviewed technical-performance summary.
Vessel-tracing sensitivity
95.8 percent
Sensitivity of vessel tracing for coronary vessels at least 1.5 mm in 425 cardiac-CTA datasets from five US states and three European countries; CT slice thickness 0.2-1.0 mm and 70-140 kVp.
Manufacturer technical-performance evaluation against expert/reference annotations · 425 cardiac-CTA datasets for vessel tracing; random 150-dataset subset for lumen and wall evaluation
exact submission · Tested version: syngo.CT Coronary Cockpit (SOMARIS/8 VC10) · n=425 · Sponsor or vendor study
K253786
The summary describes geographically diverse datasets and quantitative segmentation/tracing endpoints. It is not a prospective clinical-outcome study.
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 2026-09-06
No exact submission price or public procurement record reviewed.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable CMS policy content reviewed; no coverage conclusion is made.
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
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: The reviewed material does not provide a dated, scoped installed-configuration security assessment.
Verify training: The summary requires trained users but does not establish a current vendor training program or site competency process.
Verify pricing and total cost: No exact submission price or public procurement record reviewed.
Verify reimbursement and coding relevance: No applicable CMS policy content reviewed; no coverage conclusion is made.
Verify local validation and lifecycle monitoring: No verified product monitoring service was found. Site acceptance should evaluate coronary tracing review, edits, reporting and failure handling.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
22Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored PubMed and ClinicalTrials candidate metadata snapshots were screened; both arrays were empty. No candidate 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, acr ai central product, fda decision summary, vendor documentation, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
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