AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac function, to prepare cardiac interventions; physician review and decisions remain required.
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
AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac function, to prepare cardiac interventions; physician review and decisions remain required.
FDA source Exact FDA submission Checked 2026-09-06
Chamber and aortic-root segmentations, coronary centerlines/labels/lumen/wall information, user-defined stenosis and plaque findings, cardiac-function analysis and CAD-RADS 2.0 reporting based on user-confirmed findings.
FDA source Exact FDA submission Checked 2026-09-06
The device does not provide automatic diagnosis, clinical decisions or treatment recommendations. All outputs are reviewable and editable. Pre-PCI planning tools provide approximate vessel dimensions and C-arm angulation and are not for device selection or treatment decisions.
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
K260169
FDA source Exact FDA submission Checked 2026-08-31
Vendor confirmation Exact FDA submission Checked 2026-09-06
DICOM conformance and general connected-workflow language do not establish formal security controls for an installed configuration.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Qualified-user intent does not establish a verified current training program.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
No verified monitoring service was found. Site acceptance should evaluate input quality, centerline/segmentation review, editability and reporting.
Current AVW DICOM family context
Philips' AVW V15.1.3 DICOM conformance statement lists AV Cardiac CT within the AV Cardio Vascular Suite and describes receiving, storing, querying and exchanging DICOM images.
product family · checked 2026-09-06
This is current product-family documentation, not exact evidence for the K260169 configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
The K260169 technical study used 80 CCTA cases and three observers' manual reference annotations. It measures algorithm agreement and labeling performance rather than clinical diagnostic or treatment outcomes.
FDA source Exact FDA submission Checked 2026-09-06
Manufacturer technical-performance evaluation compared with three-observer manual reference annotations · 80 CCTA cases from datasets spanning US, Europe and Asia
exact submission · Tested version: AV Cardiac CT configuration cleared in K260169 · n=80 · Sponsor or vendor study
K260169
Endpoints include coronary centerline, label and lumen-segmentation agreement. The study is not an autonomous diagnosis or 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 public exact-version price or 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: DICOM conformance and general connected-workflow language do not establish formal security controls for an installed configuration.
Verify training: Qualified-user intent does not establish a verified current training program.
Verify pricing and total cost: No public exact-version price or 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 monitoring service was found. Site acceptance should evaluate input quality, centerline/segmentation review, editability and reporting.
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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