Radiology AI Directory

FDA-cleared profile

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra, and dynamic images of structures or functions of the body for trained-physician interpretation that may assist diagnosis. Contrast agents may be used depending on the region.

Breast imagingCardiac imagingProstate imagingMSK and bone
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
The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra, and dynamic images of structures or functions of the body for trained-physician interpretation that may assist diagnosis. Contrast agents may be used depending on the region.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Appropriately trained healthcare professionals, with image interpretation by a trained physician where stated in the exact labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital, clinic, outpatient, or other labeled clinical MR environment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Diagnostic magnetic-resonance image acquisition and display, with release-specific reconstruction or derived-image functions where labeled.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported MR acquisitions, pulse sequences, coils, and optional contrast agents within the exact labeled configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Cross-sectional MR images and, where labeled, spectra, parametric maps, dynamic images, or derived physical parameters for professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Use only the exact labeled scanner, field strength, coils, sequences, contrast conditions, patient population, and anatomy; images require trained-physician 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
K233728
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-01-19
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

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

Exact deployment topology, hosting, network boundaries, PHI flow, retention, update mechanism, and local operational requirements are not established for this submission.

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

Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.

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.

Workflow role

Diagnostic magnetic-resonance image acquisition and display, with release-specific reconstruction or derived-image functions where labeled.

exact submission · checked 2026-09-04

Submission-anchored workflow summary, not a local acceptance or deployment result.

Source

Input

Supported MR acquisitions, pulse sequences, coils, and optional contrast agents within the exact labeled configuration.

exact submission · checked 2026-09-04

Exact supported inputs and protocol limits must be confirmed from the complete labeling.

Source

Output

Cross-sectional MR images and, where labeled, spectra, parametric maps, dynamic images, or derived physical parameters for professional interpretation.

exact submission · checked 2026-09-04

Output review, editing, approval, export, and downstream use remain release- and site-specific.

Source

Deployment evidence

Exact deployment topology and operational boundaries remain unestablished.

exact submission · checked 2026-09-04

Confirm hosting, PHI flow, retention, access, updates, downtime, and support obligations before procurement or clinical use.

Source

Integration evidence

Exact local interfaces, identity matching, routing, display, reporting, and fallback behavior remain unestablished.

exact submission · checked 2026-09-04

Validate the local workflow against the exact release and enabled options.

Source

Vendor family context

Current vendor material is product-family context for K233728 only; exact release, enabled options, deployment, security, interoperability, pricing, and local workflow require confirmation.

product family · checked 2026-09-04

Vendor material is not exact-release evidence unless that linkage is separately proven.

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
The FDA decision material reports bench and sample-clinical-image evidence and states that a clinical study was not required for substantial equivalence.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-submission and version-linked sensitivity endpoint is promoted; candidate or product-family values were not substituted.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-submission and version-linked specificity endpoint is promoted; candidate or product-family values were not substituted.

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

FDA submission-specific verification and validation evidence for K233728

  • DesignFDA 510(k) regulatory decision material and submission-specific verification or validation evidence for K233728; this is regulatory evidence, not an independent clinical effectiveness study.
  • PopulationThe labeled population, anatomy, images, and test materials described in the exact FDA decision material for K233728; a broader clinical population is not established here.
  • Scopeexact submission
  • Tested versionSIGNA Champion (K233728)
  • IndependenceSponsor or vendor study

K233728

The FDA decision material reports bench and sample-clinical-image evidence and states that a clinical study was not required for substantial equivalence.

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 exact-release price, license fee, subscription, contract, or implementation cost was established in this review.

Reimbursement and coding
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

CMS coverage-index context was checked, but no product-specific coverage or reimbursement determination is inferred.

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 FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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
30Fields reviewed
11Source 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. Exact-name and exact-submission searches in the checked 2026-09-01 literature and trial indexes returned no PubMed candidate records and no ClinicalTrials.gov candidate records for K233728; the checked openFDA snapshot returned no recall candidate records. Candidate records remain quarantined unless exact product and version linkage is established. Current vendor material is product-family context only. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. 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, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, 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 K233728: SIGNA Champion

    U.S. Food and Drug Administration - Published 2024-01-19 - 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. 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. GE HealthCare MRI family context

    GE HealthCare - Accessed 2026-09-04

    Scope: productFamilyContext

Research history

  1. K233728 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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