Radiology AI Directory

FDA-cleared profile

True Enhance DL

GE Healthcare Japan Corporation

Improve contrast of 120 kVp single-energy body CT images by estimating 50 keV GSI-like images as non-quantitative adjunct information for patients of all ages; the original 120 kVp image must remain available for interpretation.

Quantification and segmentation
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
Improve contrast of 120 kVp single-energy body CT images by estimating 50 keV GSI-like images as non-quantitative adjunct information for patients of all ages; the original 120 kVp image must remain available for interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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
Revolution Ascend CT acquisition and processing workflow; facility type is not stated in the FDA packet
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing and reconstruction contrast-enhancement option within Revolution Ascend; the user selects a phase model and compares the adjunct output with the original 120 kVp image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
120 kVp single-energy, non-GSI body CT images acquired on Revolution Ascend Elite, Plus, or Select systems, using Standard, Soft, or Detail reconstruction kernels; the packet states that the input acquisition parameters are not changed.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Non-quantitative contrast-enhanced images estimating monochromatic 50 keV GSI images, with better contrast than the single-energy input; four models are available for CT angiography, arterial, portal/venous, and delayed phases.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Only 120 kVp acquisitions on non-GSI Revolution Ascend systems are covered. The output is not quantitative, must not be interpreted without the original 120 kVp image, and is not intended to replace hardware-based GSI or replicate dual-energy acquisition. The FDA indication allows patients of all ages but does not establish a broader modality or system scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K233698
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Body
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-04-11
  • 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 option is deployed within Revolution Ascend acquisition and processing software on the same hardware and software platform. The packet does not establish DICOM, PACS, RIS, EHR, external interface, or standalone deployment details.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for True Enhance DL; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท checked 2026-09-08
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
FDA K233698 reports design verification, phantom and image-quality testing using IEC 61223-3-5-related metrics, a retrospective reader study in which four board-certified radiologists compared diagnostic-use image quality and contrast, and material comparisons with 50 keV and 120 kVp reference images. The reviewed FDA text reports qualitative image-quality and contrast validation but no sample size or numerical clinical diagnostic-performance metrics.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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.

True Enhance DL regulatory performance study summary

  • DesignReader Study
  • PopulationAdult and Pediatric
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K233698
  • IndependenceIndependence not established

K233698

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 2026-09-08

No public price or quote for the exact K233698 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K233698. 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 2026-09-08

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
2026-09-08Last searched
19Fields reviewed
9Source 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 scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. 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, 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 K233698: True Enhance DL

    U.S. Food and Drug Administration - Published 2024-04-11 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. True Enhance DL model card (K233698)

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

    Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies

  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 K233698

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K233698 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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