Radiology AI Directory

FDA-cleared profile

Deep Learning Image Reconstruction for Gemstone Spectral Imaging

GE Medical Systems, LLC

Performs deep-learning CT reconstruction from dual-energy X-ray transmission data acquired with Gemstone Spectral Imaging.

CT/CTA workflow
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

Performs deep-learning CT reconstruction from dual-energy X-ray transmission data acquired with Gemstone Spectral Imaging.

Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.

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
Performs deep-learning CT reconstruction from dual-energy X-ray transmission data acquired with Gemstone Spectral Imaging.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.

Intended users
Board-certified radiologists
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult and Pediatric
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Acquisition or image-processing support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Dual-energy data with standard kernel from named Revolution CT family systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA packet input and system scope.

Output and human action
DICOM-compatible TrueFidelity CT images, monochromatic, material-decomposition, and VUE outputs at Low, Medium, or High strength.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA packet output scope.

Limitations
Compatibility is limited to named Revolution CT family models and does not establish all-manufacturer support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Exact FDA limitation boundary.

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
K201745
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA CT scope normalized to controlled CT bucket.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

FDA scope covers whole body, vascular, and contrast-enhanced head applications.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-12-10
  • 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-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.

Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

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

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Deep Learning Image Reconstruction for Gemstone Spectral Imaging; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
Bench testing plus a 40-case reader study with five board-certified radiologists and seven additional challenge cases were reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-15

Submission-reported testing; same-or-better comparison is not independent validation.

Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

Deep Learning Image Reconstruction for Gemstone Spectral Imaging Overview regulatory performance study summary

  • DesignReader Study
  • PopulationAdult and Pediatric
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K201745
  • IndependenceIndependence not established

K201745

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K201745 configuration was established in this review.

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

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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 exact-identifier FDA recall query returned no native recall record for K201745. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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
2026-09-15Last searched
23Fields reviewed
10Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA decision-summary packet reviewed on 2026-09-15. Applied FDA-supported reader facts: purpose, modality, anatomy, input, output, limitations, evidenceSummary. Facts marked unknown in the FDA packet retain any prior non-FDA source without reclassification. Candidate literature and postmarket candidates remain in their existing review state. 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, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, 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 K201745: Deep Learning Image Reconstruction for Gemstone Spectral Imaging

    U.S. Food and Drug Administration - Published 2020-12-10 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Deep Learning Image Reconstruction for Gemstone Spectral Imaging Overview model card (K201745)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

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

  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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K201745

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

    Scope: postmarketSafety

Research history

  1. K201745 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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