Radiology AI Directory

FDA-cleared profile

Vereos PET/CT

Philips Medical Systems Nederland B.V.

Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and radiotherapy-planning support.

Radiotherapy planningOncology quantificationDetection and CADeNuclear medicine
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
Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and radiotherapy-planning support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Qualified nuclear medicine physicians, radiologists, technologists, and other trained PET/CT professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospital or outpatient molecular-imaging departments using the cleared PET/CT configuration and radiopharmaceutical workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
PET/CT acquisition, reconstruction, attenuation correction, fusion, visualization, and quantitative review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Positron-emission data, CT transmission data, patient and protocol information, and supported radiopharmaceutical studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Attenuation-corrected PET, CT, fused PET/CT, quantitative, and planning images for professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Use only cleared radiopharmaceuticals, scan ranges, reconstruction options, and patient or planning workflows; PET Adaptive Reconstruction is a reconstruction option and is not evidence of an independent diagnostic classifier.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

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
K211764
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
PET/SPECT/Nuclear Medicine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2021-08-06
  • 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
PET/CT console and DICOM workflow to PACS, oncology, radiotherapy, or reporting systems; validate radiopharmaceutical labels, patient matching, attenuation maps, series labels, SUV or quantitative values, and routing.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K211764; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Installed PET/CT scanner, console, reconstruction options, and supported clinical or radiotherapy interfaces.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K211764; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

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 nuclear medicine physicians, radiologists, technologists, and other trained pet/ct professionals 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 2026-09-03
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: Use only cleared radiopharmaceuticals, scan ranges, reconstruction options, and patient or planning workflows; PET Adaptive Reconstruction is a reconstruction option and is not evidence of an independent diagnostic classifier.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K211764; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K211764 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

PET/CT console and DICOM workflow to PACS, oncology, radiotherapy, or reporting systems; validate radiopharmaceutical labels, patient matching, attenuation maps, series labels, SUV or quantitative values, and routing.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

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. Use only cleared radiopharmaceuticals, scan ranges, reconstruction options, and patient or planning workflows; PET Adaptive Reconstruction is a reconstruction option and is not evidence of an independent diagnostic classifier.

exact submission · checked 2026-09-03

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 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

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: Use only cleared radiopharmaceuticals, scan ranges, reconstruction options, and patient or planning workflows; PET Adaptive Reconstruction is a reconstruction option and is not evidence of an independent diagnostic classifier.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

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
K211764 describes optional offline PET Adaptive Reconstruction, an AI-powered reconstruction that reduces noise and improves low-contrast detectability relative to OSEM. The FDA package reports nonclinical, software, regression, and simulated-use or sample-clinical-image review; it does not establish a product-specific diagnostic sensitivity or specificity claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

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

K211764 FDA performance package for Vereos PET/CT

  • DesignManufacturer nonclinical PET/CT, PET Adaptive Reconstruction, software, regression, and simulated-use validation
  • PopulationWhole-body, cardiac, brain, lung, gastrointestinal, bone, lymphatic, and organ PET/CT workflows across oncology, cardiology, and neurology
  • Scopeexact submission
  • Tested versionVereos PET/CT
  • IndependenceSponsor or vendor study

K211764

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

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 2026-09-03

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 2026-09-03

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 K211764 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

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
25Fields reviewed
11Source classes checked
8Awaiting review PubMed leads
3Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 8 PubMed and 3 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, 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. K211764 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  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 Vereos PET/CT learning center

    Philips - Accessed 2026-09-03

    Scope: productFamilyContext, integration, deployment

  8. Performance Evaluation of the Vereos PET/CT System According to the NEMA NU2-2012 Standard.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. PET/CT background noise and its effect on speech recognition.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Impact of a PMMA tube on performances of a Vereos PET/CT system adapted for BSL-3 environment according to the NEMA NU2-2012 standard.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Comparison of PMT-based TF64 and SiPM-based Vereos PET/CT systems for (90) Y imaging and dosimetry optimization: A quantitative study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. UR-cycleGAN: Denoising full-body low-dose PET images using cycle-consistent Generative Adversarial Networks.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. SUV variability in EARL-accredited conventional and digital PET.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. Open-source phantom with dedicated in-house software for image quality assurance in hybrid PET systems.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Comparative study of physiological FDG uptake in small structures between silicon photomultiplier-based PET and conventional PET.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  16. PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  17. PROnostic Interest of 18F-FDG PET/CT in Patients With Metastatic Castration-resistant Prostate Cancer (mCPRC) Progressing

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  18. Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K211764 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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