Radiology AI Directory

FDA-cleared profile

Precision DL

GE Healthcare

Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.

Oncology quantificationNuclear 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.

Product overview

Start with the essentials

Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.

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
Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Qualified nuclear medicine physicians, radiologists, technologists, and trained PET/CT professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
PET/CT departments using a compatible scanner, supported acquisition, and the labeled reconstruction workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
PET image denoising, reconstruction, or quantitative image-processing support before professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Supported PET sinogram, list-mode, or reconstructed DICOM data and required CT or acquisition metadata.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Processed PET image series, quantitative values, and visual identifiers for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Precision DL evidence in K223212 is specific to non-time-of-flight F-18 FDG PET and the tested scanner and reader-study conditions; do not extend it to other tracers, scanners, reconstruction paths, or diagnostic endpoints.
  • 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
K223212
  • 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
2023-04-27
  • 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 reconstruction or DICOM node workflow to PACS and workstations; validate radiopharmaceutical, series identity, SUV or quantitative integrity, routing, and fallback to the standard reconstruction.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K223212; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Software integrated with the supported PET/CT scanner or deployed as a connected DICOM processing service.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K223212; 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 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: Precision DL evidence in K223212 is specific to non-time-of-flight F-18 FDG PET and the tested scanner and reader-study conditions; do not extend it to other tracers, scanners, reconstruction paths, or diagnostic endpoints.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K223212; 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 K223212 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 reconstruction or DICOM node workflow to PACS and workstations; validate radiopharmaceutical, series identity, SUV or quantitative integrity, routing, and fallback to the standard reconstruction.

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. Precision DL evidence in K223212 is specific to non-time-of-flight F-18 FDG PET and the tested scanner and reader-study conditions; do not extend it to other tracers, scanners, reconstruction paths, or diagnostic endpoints.

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: Precision DL evidence in K223212 is specific to non-time-of-flight F-18 FDG PET and the tested scanner and reader-study conditions; do not extend it to other tracers, scanners, reconstruction paths, or diagnostic endpoints.

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
K223212 reports phantom and clinical datasets and a reader study using 80 PET/CT examinations, with 40 from Omni Legend and 40 from Discovery MI across multiple sites. The FDA package supports the tested F-18 FDG oncology reconstruction workflow; the public summary does not establish a universal diagnostic-performance value.
  • 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.

Reader-study PET/CT examinations

80 examinations

  • EndpointPrecision DL clinical reader study
  • PopulationPrecision DL
  • Tested versionPrecision DL
Source

Omni Legend examinations

40 examinations

  • EndpointPrecision DL clinical reader study
  • PopulationPrecision DL
  • Tested versionPrecision DL
Source

Discovery MI examinations

40 examinations

  • EndpointPrecision DL clinical reader study
  • PopulationPrecision DL
  • Tested versionPrecision DL
Source

K223212 FDA performance package for Precision DL

  • DesignManufacturer phantom, clinical-image, and multi-reader PET reconstruction validation
  • Population80 F-18 FDG PET/CT examinations from Omni Legend and Discovery MI across multiple sites
  • Scopeexact submission
  • Tested versionPrecision DL
  • IndependenceSponsor or vendor study

K223212

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

Source

3 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 K223212 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
6Awaiting 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 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 6 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, 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. K223212 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. GE Omni Legend PET/CT

    GE HealthCare - Accessed 2026-09-03

    Scope: productFamilyContext, workflowRole, implementationCapabilities

  8. Innovations in clinical PET image reconstruction: advances in Bayesian penalized likelihood algorithm and deep learning.

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

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. Effects of a deep learning-based image quality enhancement method on a digital-BGO PET/CT system for (18)F-FDG whole-body examination.

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

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Deep Learning-Assisted Design of Novel Donor-Acceptor Combinations for Organic Photovoltaic Materials with Enhanced Efficiency.

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

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Impact of Deep Learning-Based Time-of-Flight PET Images of Small Tumors Using a Human Anatomic Phantom.

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

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. Studying Complex Evolution of Hyperelastic Materials under External Field Stimuli using Artificial Neural Networks with Spatiotemporal Features in a Small-Scale Dataset.

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

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Performance Characteristics of a New-Generation Digital Bismuth Germanium Oxide PET/CT System, Omni Legend 32, According to NEMA NU 2-2018 Standards.

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

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K223212 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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