Radiology AI Directory

FDA-cleared profile

Xeleris V Processing and Review Systems

GE Healthcare

Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from gamma cameras or PET scanners. PET or nuclear-medicine data may be registered or fused with CT or MR and physiologic signals to depict, localize, or quantify radionuclide tracers and anatomical structures. The labeled applications include DaTQUANT review of 123I-ioflupane images, Q.Lung support for pulmonary embolism, COPD, emphysema, lung-function assessment, and resection planning, and Q.Brain review of brain metabolic function or blood flow in specified neurologic conditions.

Pulmonary embolismQuantification and segmentationNuclear 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
Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from gamma cameras or PET scanners. PET or nuclear-medicine data may be registered or fused with CT or MR and physiologic signals to depict, localize, or quantify radionuclide tracers and anatomical structures. The labeled applications include DaTQUANT review of 123I-ioflupane images, Q.Lung support for pulmonary embolism, COPD, emphysema, lung-function assessment, and resection planning, and Q.Brain review of brain metabolic function or blood flow in specified neurologic conditions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified radiologists, nuclear-medicine physicians, and trained imaging professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Clinical molecular-imaging and radiology environments within the labeled workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Nuclear-medicine image acquisition support, reconstruction, display, quantification, analysis, or comparison under professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported PET, SPECT, nuclear-medicine, CT, MR, tracer, physiologic-signal, and study inputs described in the labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Processed, fused, quantitative, comparative, and report-ready molecular-imaging views for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Radiopharmaceutical, scan, reconstruction, quantitative, anatomy, and patient limits are exact-configuration dependent; clinical decisions remain with qualified clinicians.
  • 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
K201103
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
PET/SPECT/Nuclear Medicine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Whole-body, lung, brain/striatum, and other anatomy represented in nuclear-medicine, PET, CT, and MR studies
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-09-25
  • 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 exact FDA package describes nuclear-medicine and PET data with registered or fused CT or MR and physiologic signals, plus networking and reporting functions; verify local interfaces, identity, routing, and archive behavior.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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

Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

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 qualified radiologists, nuclear-medicine physicians, and trained imaging 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 2026-09-04
Monitoring and change control
Monitor K201103 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: Radiopharmaceutical, scan, reconstruction, quantitative, anatomy, and patient limits are exact-configuration dependent; clinical decisions remain with qualified clinicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is 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 K201103 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared or authorized 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 topology does not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact FDA package describes nuclear-medicine and PET data with registered or fused CT or MR and physiologic signals, plus networking and reporting functions; verify local interfaces, identity, routing, and archive behavior.

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. Radiopharmaceutical, scan, reconstruction, quantitative, anatomy, and patient limits are exact-configuration dependent; clinical decisions remain with qualified clinicians.

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.

exact submission · checked 2026-09-04

No exact-product price or reimbursement determination was promoted.

Source

Lifecycle monitoring

Monitor K201103 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: Radiopharmaceutical, scan, reconstruction, quantitative, anatomy, and patient limits are exact-configuration dependent; clinical decisions remain with qualified clinicians.

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
K201103 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
  • 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, study design, and source if separately 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, study design, and source if separately verified.

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

K201103 FDA decision evidence package for Xeleris V Processing and Review Systems

  • DesignFDA decision evidence and product verification described in the exact submission or PMA decision record.
  • PopulationWhole-body, lung, brain/striatum, and other anatomy represented in nuclear-medicine, PET, CT, and MR studies
  • Scopeexact submission
  • Tested versionXeleris V Processing and Review Systems configuration described in K201103
  • IndependenceSponsor or vendor study

K201103

FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; 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 or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

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

No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.

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 K201103 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.

Exact FDA record reviewedStatus
2026-09-04Last searched
26Fields reviewed
7Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Scope was limited to exact FDA decision material and exact-submission recall disposition already present in the checked snapshot. Optional literature, vendor, pricing, and deployment research was not promoted. Automated exact-name discovery found 0 PubMed and 0 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, 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 K201103: Xeleris V Processing and Review Systems

    U.S. Food and Drug Administration - Published 2020-09-25 - 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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K201103 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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