Adjunctive cardiovascular review for radiologists and physicians in emergency medicine, specialty care, urgent care and general practice, including heart volume, coronary calcium volume, aortic segmentation, aortic diameter measurement and threshold-based highlighting of enlarged diameters.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct 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
Adjunctive cardiovascular review for radiologists and physicians in emergency medicine, specialty care, urgent care and general practice, including heart volume, coronary calcium volume, aortic segmentation, aortic diameter measurement and threshold-based highlighting of enlarged diameters.
Clinical radiology and physician-care settings using previously acquired adult CT examinations, including emergency, urgent, specialty and general practice workflows.
Adjunctive quantitative and qualitative clinical decision support for qualified clinicians; outputs support interpretation and assessment and do not replace professional review.
Previously acquired DICOM CT images from adult patients. FDA validation covered non-cardiac chest CT with filtered-backprojection reconstruction from Siemens, GE, Philips and Toshiba/Canon systems; calcium detection also included Siemens iterative reconstruction.
Heart segmentation and volume, total coronary calcium volume, aorta segmentation, aortic diameters at predefined and maximum-diameter locations, threshold-based diameter categories/highlighting, quantitative and textual reports, DICOM Secondary Capture and DICOM Structured Report TID 1500 outputs.
Only adult DICOM input is labeled in the exact submission. The validated CT reconstruction, scanner, slice and image-quality conditions limit direct generalization; the submission states that no clinical tests were conducted for the introduced modifications, with verification and validation used instead. Outputs require qualified-clinician review.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact submission describes DICOM CT input and forwarding of quantitative, structured and textual reports plus DICOM Secondary Capture to PACS; VA20 adds a human- and machine-readable DICOM Structured Report using TID 1500.
The VA20 submission describes both cloud and edge on-premise deployments; the edge configuration processes data and results in the customer environment while remaining connected to the cloud for monitoring and maintenance.
The reviewed sources do not establish exact VA20 security controls, retention or assurance documentation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Cloud and edge/on-premise deployment
The VA20 submission describes cloud and edge on-premise deployments, with edge processing in the customer environment while remaining connected to the cloud for monitoring and maintenance.
VA20 generates quantitative, structured and textual reports, DICOM Secondary Capture and a human- and machine-readable DICOM Structured Report using TID 1500 for transfer to clinical systems.
Siemens' current family whitepaper describes reconstructed thorax CT being sent to PACS and in parallel to AI-Rad Companion, with results delivered to web-based review or directly to PACS and used with original data for reporting.
product family · checked 2026-09-07
The reviewed whitepaper covers current VA40A/VA22A family material; it does not establish that every feature or connector is present in K222360 VA20.
Review, accept/decline and send-to-PACS interaction
The Siemens cardiovascular job aid shows calcium and heart-volume findings, nine aortic landmarks with diameters and threshold-based color coding; users can accept or decline findings before sending the case to PACS.
product family · checked 2026-09-07
This is 2019 training material, explicitly not an operator manual and not necessarily current; optional functions and country availability require confirmation.
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 validation reported subject aorta-segmentation Dice 0.924 ± 0.046 in 315 retrospective cases. In 193 cases, including 50% with dilated aorta and 9% with aortic aneurysm, subject aortic diameter bias at nine landmarks was within ±1.5 mm and MAE was at most 2.2 mm; maximum ascending/descending aorta measurements had 95% limits of agreement ±3.51 mm with 91.9% within those limits.
DesignRepresentative retrospective clinical cohort with Bland-Altman analysis of nine predefined landmarks and maximum ascending/descending aorta measurements.
Population193 adult CT cases, including 50% with dilated aorta and 9% with aortic aneurysm.
Scopeexact product version
Tested versionAI-Rad Companion (Cardiovascular) VA20 submitted in K222360
Samplen=193
IndependenceSponsor or vendor study
K222360
The submission states that no clinical tests were conducted for the introduced modifications; the reported evidence is clinical-data-based software validation and verification/validation.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact product version
Checked 2026-09-07
No public price or quote for the exact VA20 configuration was reviewed.
Reimbursement and coding
Research pending
Needs research
Exact product version
Checked 2026-09-07
Payer policy research was outside this worker's scope.
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 product version
Checked 2026-09-07
The exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: The reviewed sources do not establish exact VA20 security controls, retention or assurance documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public price or quote for the exact VA20 configuration was reviewed.
Verify reimbursement and coding relevance: Payer policy research was outside this worker's scope.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: The exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
23Fields reviewed
11Source classes checked
20Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened. The broad AI-Rad Companion query returned 20 PubMed and one trial identifier without exact K222360 VA20 linkage established in metadata; no full paper or trial record was reviewed, and no candidate is promoted as product evidence. The current discovery snapshot contains 20 PubMed and 1 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, vendor technical documentation, vendor training material, stored candidate metadata, literature index, trial registry, 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 history8 sources - 2 history items
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