FDA-cleared profile
Ge Healthcare Japan Corporation
Authorized purpose: True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
Product overview
Authorized purpose: True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
Overview status: Source-reviewed overview
Clinical role: True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
Evidence from the reviewed source record: The exact FDA decision material describes a three-strength deep-learning reconstruction function implemented on compatible Revolution CT and Apex family systems, with design-control and MTF spatial-resolution evaluation. No universal diagnostic sensitivity or specificity claim is established.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
The public exact-submission material does not establish a complete integration contract. Confirm DICOM, worklist, identity, interfaces, exports, routing, audit behavior, and downtime locally.
The public exact-submission material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
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.
Current vendor material is product-family context for K253686; confirm exact cleared version, enabled options, deployment, and local compatibility.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253686 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, and downtime contract locally.
product family · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.
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. Bench, phantom, and reader results do not establish universal dose reduction or diagnostic performance across every anatomy, protocol, patient size, or downstream quantitative application.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
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: Bench, phantom, and reader results do not establish universal dose reduction or diagnostic performance across every anatomy, protocol, patient size, or downstream quantitative application.
product family · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.
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.
Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.
Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K253686
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamilyContext, workflowRole, implementationCapabilities
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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