Authorized 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.
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: 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.
Overview status: Source-reviewed overview
What does this software do?Authorized 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.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Heart/Cardiovascular Input: Gated conventional or spectral cardiac CT data, including coronary CT angiography datasets.
Who uses it?Intended users: Qualified medical professionals, including radiologists, cardiologists and 3D technologists.
What does the software produce?Output: 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.
What is its most important limitation?Key limitation: 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.
Clinical takeaway
Clinical role: 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 takeaway
Evidence from the reviewed source record: 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.
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
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.
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.
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.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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 ยท 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. Candidate literature without exact product and version linkage is not shown as product evidence.
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.
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
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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