Radiology AI Directory

FDA-cleared profile

EchoNavigator R5.0

Philips Medical Systems Nederland B.V.

Authorized purpose: EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.

Cardiac imaging
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: EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA decision material describes compatibility with Philips echocardiography probes and units and interventional X-ray systems, substantial equivalence to EchoNavigator R4.0, no clinical study requirement, and nonclinical testing.

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
EchoNavigator R5.0 supports an interventionalist or surgeon during cardiovascular treatment by combining live X-ray and live echocardiographic information.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified interventional physicians, surgeons, radiologists, technologists, and other trained procedural staff.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital interventional, cardiovascular, operating-room, or procedure-suite workflows within the cleared indication.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Image registration, fusion, localization, or procedural guidance under direct professional control.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported live X-ray, echocardiographic, CT, or other labeled images and procedure-specific user inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Registered images, landmarks, overlays, measurements, or navigation guidance for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The operator remains responsible for source-image review, target confirmation, calibration, and fallback when inputs, registration, tracking, or output quality are inadequate.
  • 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
K253614
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Fluoroscopy/Angiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Heart and cardiovascular structures
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-03-17
  • 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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The public exact-submission material does not establish a complete integration contract. Confirm DICOM, worklist, identity, interfaces, exports, routing, audit behavior, and downtime locally.

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

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

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • 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 qualified interventional physicians, surgeons, radiologists, technologists, and other trained procedural staff should operate or interpret the product. Local onboarding should 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 by exact hardware, software, model, and 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: The operator remains responsible for source-image review, target confirmation, calibration, and fallback when inputs, registration, tracking, or output quality are inadequate.
  • Public source
  • Product family
  • Checked 2026-09-04

Current vendor material is product-family context for K253614; confirm exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253614 before acceptance.

exact submission · checked 2026-09-04

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

Source

Interoperability acceptance

Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, and downtime contract locally.

product family · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

SourceSource

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. The operator remains responsible for source-image review, target confirmation, calibration, and fallback when inputs, registration, tracking, or output quality are inadequate.

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 by exact hardware, software, model, and 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: The operator remains responsible for source-image review, target confirmation, calibration, and fallback when inputs, registration, tracking, or output quality are inadequate.

product family · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

SourceSource

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
The exact FDA decision material describes compatibility with Philips echocardiography probes and units and interventional X-ray systems, substantial equivalence to EchoNavigator R4.0, no clinical study requirement, and nonclinical testing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.

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

Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K253614 FDA evidence package for EchoNavigator R5.0

  • DesignFDA software substantial-equivalence decision with nonclinical image-registration, display, compatibility, and usability verification
  • PopulationCardiovascular interventional procedures using compatible live X-ray and live echocardiography inputs
  • Scopeexact submission
  • Tested versionK253614 exact FDA configuration
  • IndependenceSponsor or vendor study

K253614

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

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, procedural, or surgical service line and verify payer, site-of-service, and coding 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

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

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 K253614 by exact native submission identifier. This does not exclude product-family, later, 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
2026-09-20Last searched
27Fields reviewed
12Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 history

Source ledger

  1. FDA 510(k) decision material K253614: EchoNavigator R5.0

    U.S. Food and Drug Administration - Published 2026-03-17 - Accessed 2026-09-04

    Scope: identity, 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. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

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

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Philips EchoNavigator family

    Philips - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

Research history

  1. K253614 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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