Radiology AI Directory

FDA-cleared profile

Axial3D Insight

Axial Medical Printing Limited

Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic, maxillofacial, cardiovascular, and treatment-planning workflows; final decisions require expert review.

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
Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic, maxillofacial, cardiovascular, and treatment-planning workflows; final decisions require expert review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified imaging professionals and physicians trained for the represented anatomy and workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital or outpatient imaging analysis, reporting, or surgical-planning environments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Medical-image processing, measurement, quantification, visualization, and reporting support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported DICOM images, study metadata, and release-specific user inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Measurements, segmentations, visualizations, calculations, models, and reports for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Outputs supplement accepted interpretation or planning methods and require review against source images; supported modality, anatomy, protocol, patient population, and version limits apply.
  • 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
K250369
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Trauma, orthopedic, maxillofacial, and cardiovascular anatomy
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-09-18
  • 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 FDA material describes DICOM transfer to and from the image-segmentation service; validate identity, access, transfer, latency, output review, archive, and downtime locally.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

The exact FDA package describes the indicated input or interface boundary; local interoperability acceptance remains necessary.

Deployment and data flow
The exact FDA material describes a cloud-based image-segmentation service; the hosting region, contractual controls, security architecture, availability, and local deployment responsibility remain unverified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

The exact FDA package describes this release-level deployment boundary; hosting, contracts, security, availability, and site configuration remain separate evidence.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-04

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 imaging professionals and physicians trained for the represented anatomy and workflow 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 2026-09-04
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: Outputs supplement accepted interpretation or planning methods and require review against source images; supported modality, anatomy, protocol, patient population, and version limits apply.
  • Public source
  • Product family
  • Checked 2026-09-04

Current vendor material is product-family context for K250369; confirm exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K250369 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

The exact FDA material describes DICOM transfer to and from the image-segmentation service; validate identity, access, transfer, latency, output review, archive, and downtime locally.

product family · checked 2026-09-04

Test 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.

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. Outputs supplement accepted interpretation or planning methods and require review against source images; supported modality, anatomy, protocol, patient population, and version limits apply.

exact submission · checked 2026-09-04

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 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

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: Outputs supplement accepted interpretation or planning methods and require review against source images; supported modality, anatomy, protocol, patient population, and version limits apply.

product family · checked 2026-09-04

Revalidate 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.

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
The exact FDA decision material describes DICOM transfer, machine-learning initial segmentation, expert final review, validation and usability testing, and controlled model changes that are trained, tuned, and locked before release rather than continuously learned in the field.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

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.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

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.

K250369 FDA evidence package for Axial3D Insight

  • DesignFDA software substantial-equivalence decision with DICOM, cloud workflow, segmentation, model generation, change control, validation, and usability evidence
  • PopulationPatient-specific trauma, orthopedic, maxillofacial, cardiovascular, and treatment-planning studies using supported DICOM images
  • Scopeexact submission
  • Tested versionAxial3D Insight configuration described in K250369
  • IndependenceSponsor or vendor study

K250369

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.

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 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 2026-09-04

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 K250369 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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
26Fields 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 indexes returned no PubMed records and no ClinicalTrials.gov records for K250369; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. Current vendor material is product-family context. 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, 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. FDA 510(k) decision material K250369: Axial3D Insight

    U.S. Food and Drug Administration - Published 2025-09-18 - Accessed 2026-09-04

    Scope: identity, 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. Axial3D Insight family

    Axial3D - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

Research history

  1. K250369 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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