Radiology AI Directory

FDA-cleared profile

AV Vascular

Philips Medical Systems Nederland B.V.

AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular pathology and pre-procedural endovascular planning.

Quantification and segmentation
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
AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular pathology and pre-procedural endovascular planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiologists, vascular specialists, interventional radiologists, surgeons, and other trained healthcare professionals reviewing vascular CTA or MRA.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital and clinical vascular imaging, radiology, and pre-procedural planning workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Segments vessels, creates centerlines and lumen or outer-wall views, provides measurements, and supports review and planning of vascular anatomy.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported CTA and/or MRA medical-image datasets, including vascular studies selected for segmentation and planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
2D, MIP, MPR, cMPR, sMPR, path-aligned, and 3D displays; vessel centerlines; lumen and outer-wall segmentations; diameters, areas, lengths, angles, ring markers, reports, and exports.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Use is limited to the supported CTA/MRA anatomy, segmentation, measurements, and pre-procedural workflow; the FDA material warns that accuracy may be reduced for giant aneurysms larger than 10 cm, and clinicians retain final interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

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
K253735
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Vascular anatomy; head/neck, body, aorta, iliac and subclavian vessels
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-01-22
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The FDA material describes CTA/MRA input, multiple 2D and 3D visualization paths, segmentation, centerline and measurement outputs, reports, exports, and ring-marker planning functions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.

Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only Radiologists, vascular specialists, interventional radiologists, surgeons, and other trained healthcare professionals reviewing vascular CTA or MRA should operate or interpret the product; local onboarding must cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K253735 by exact hardware, software, model, algorithm version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: Use is limited to the supported CTA/MRA anatomy, segmentation, measurements, and pre-procedural workflow; the FDA material warns that accuracy may be reduced for giant aneurysms larger than 10 cm, and clinicians retain final interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253735 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The FDA material describes CTA/MRA input, multiple 2D and 3D visualization paths, segmentation, centerline and measurement outputs, reports, exports, and ring-marker planning functions.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use is limited to the supported CTA/MRA anatomy, segmentation, measurements, and pre-procedural workflow; the FDA material warns that accuracy may be reduced for giant aneurysms larger than 10 cm, and clinicians retain final interpretation.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K253735 by exact hardware, software, model, algorithm version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source

Evidence

Performance evidence

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
K253735 FDA material reports outer-wall segmentation validation in 80 patients from seven U.S., three European, and one Asian site, with 3D and 2D Dice, mean-surface-distance, Hausdorff-distance, and diameter-error endpoints; the evidence is exact-version and task-specific.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Outer-wall segmentation 3D Dice

0.96 Dice coefficient

  • Endpoint3D aorto-iliac outer-wall segmentation agreement
  • Population80-patient multi-site validation cohort
  • Tested versionAV Vascular configuration described in K253735
Source

Outer-wall segmentation 2D Dice

0.96 Dice coefficient

  • Endpoint2D aorto-iliac outer-wall segmentation agreement
  • Population80-patient multi-site validation cohort
  • Tested versionAV Vascular configuration described in K253735
Source

Outer-wall mean surface distance

0.57 mm

  • EndpointMean surface distance for outer-wall segmentation
  • Population80-patient multi-site validation cohort
  • Tested versionAV Vascular configuration described in K253735
Source

Outer-wall Hausdorff distance

1.68 mm

  • EndpointHausdorff distance for outer-wall segmentation
  • Population80-patient multi-site validation cohort
  • Tested versionAV Vascular configuration described in K253735
Source

Minimum-diameter error within 5 mm

98.8 percent

  • EndpointProportion of diameter errors within 5 mm for minimum diameter
  • Population80-patient multi-site validation cohort
  • Tested versionAV Vascular configuration described in K253735
Source

Maximum-diameter error within 5 mm

98.5 percent

  • EndpointProportion of diameter errors within 5 mm for maximum diameter
  • Population80-patient multi-site validation cohort
  • Tested versionAV Vascular configuration described in K253735
Source

K253735 FDA evidence package for AV Vascular

  • DesignFDA 510(k) retrospective multi-site vascular segmentation and measurement validation.
  • Population80 patients with aorto-iliac vascular studies from seven U.S., three European, and one Asian site, independent from training sites.
  • Scopeexact submission
  • Tested versionAV Vascular configuration described in K253735
  • Samplen=80
  • Sites11
  • IndependenceSponsor or vendor study

K253735

The FDA material also describes centerline, ring-marker, and subclavian tests; no broader clinical-outcome claim is promoted.

Source

Costs and setup

Budget and ongoing governance

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 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.

Source

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
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K253735 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
32Fields reviewed
10Source classes checked
16Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

Screened 16 PubMed and one ClinicalTrials.gov record. Their AV or vascular wording concerns arteriovenous access, thrombosis, or unrelated biology rather than Philips AV Vascular or K253735; all 17 were quarantined and none was promoted. The current discovery snapshot contains 16 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, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 history

Source ledger

  1. FDA 510(k) decision material K253735: AV Vascular

    U.S. Food and Drug Administration - Published 2026-01-22 - Accessed 2026-09-04

    Scope: identity, productIdentity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. AV Vascular model card (K253735)

    American College of Radiology - Published 2026-09-01 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K253735 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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