Authorized 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.
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: 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.
Overview status: Source-reviewed overview
What does this software do?Authorized 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.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Heart/Cardiovascular Input: Cardiac CT angiography volume datasets in the syngo.via environment.
Who uses it?Intended users: Trained users with appropriate skill, experience and judgment; a physician is responsible for confirming lesion presence or absence and clinical use of results.
What does the software produce?Output: Processed coronary-vessel visualization, quantification and reporting information for physician confirmation and documentation.
What is its most important limitation?Key limitation: 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.
Clinical takeaway
Clinical role: 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 takeaway
Evidence from the reviewed source record: 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.
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
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.
Trained users with appropriate skill, experience and judgment; a physician is responsible for confirming lesion presence or absence and clinical use of results.
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.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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 ยท 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. Candidate literature without exact product and version linkage is not shown as product evidence.
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.
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
0Screened PubMed leads
0Screened 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
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history7 sources - 3 history items
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