Radiology AI Directory

FDA-cleared profile

Axial3D Insight

Axial Medical Printing Limited

Authorized purpose: Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled trauma, orthopedic, maxillofacial, and cardiovascular fields.

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.

Product overview

Start with the essentials

Authorized purpose: Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled trauma, orthopedic, maxillofacial, and cardiovascular fields.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled trauma, orthopedic, maxillofacial, and cardiovascular fields.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA material describes a clinical segmentation performance study with 3 radiologists reviewing 12 cases and an intended-use validation study with 9 physicians reviewing 12 cases across orthopedic, trauma, maxillofacial, and cardiovascular fields.

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 service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled trauma, orthopedic, maxillofacial, and cardiovascular fields.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained healthcare professionals, physicians, technicians, surgeons, or other users specified by the exact submission.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Healthcare institution, clinical image-review, surgical-planning, or other labeled environment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Medical-image viewing, processing, segmentation, measurement, registration, communication, or planning support within the exact labeled scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
DICOM or other medical-image data from the exact labeled modalities, scanners, and user workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Images, measurements, segmentations, models, reports, or planning information for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Supported modalities, modules, anatomy, patient population, and output use are submission-specific; source images and generated results require expert review.
  • 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
K232841
  • 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
Patient-specific anatomy in trauma, orthopedic, maxillofacial, and cardiovascular applications
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-15
  • 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 indication describes DICOM transfer from a medical scanner; local routing, patient matching, export, fabrication, and review controls require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
The exact FDA indication describes a cloud-based service; cloud region, PHI flow, retention, access control, update mechanism, and local operational requirements are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Workflow role

Medical-image viewing, processing, segmentation, measurement, registration, communication, or planning support within the exact labeled scope.

exact submission · checked 2026-09-04

Submission-anchored workflow summary, not a local acceptance or deployment result.

Source

Input

DICOM or other medical-image data from the exact labeled modalities, scanners, and user workflow.

exact submission · checked 2026-09-04

Exact supported inputs and protocol limits must be confirmed from the complete labeling.

Source

Output

Images, measurements, segmentations, models, reports, or planning information for professional review.

exact submission · checked 2026-09-04

Output review, editing, approval, export, and downstream use remain release- and site-specific.

Source

Deployment evidence

The exact FDA indication describes a cloud-based service; cloud region, PHI flow, retention, access control, update mechanism, and local operational requirements are not established.

exact submission · checked 2026-09-04

Confirm hosting, PHI flow, retention, access, updates, downtime, and support obligations before procurement or clinical use.

Source

Integration evidence

The exact FDA indication describes DICOM transfer from a medical scanner; local routing, patient matching, export, fabrication, and review controls require confirmation.

exact submission · checked 2026-09-04

Validate the local workflow against the exact release and enabled options.

Source

Vendor family context

Current vendor material is product-family context for K232841 only; exact release, enabled options, deployment, security, interoperability, pricing, and local workflow require confirmation.

product family · checked 2026-09-04

Vendor material is not exact-release evidence unless that linkage is separately proven.

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
The exact FDA material describes a clinical segmentation performance study with 3 radiologists reviewing 12 cases and an intended-use validation study with 9 physicians reviewing 12 cases across orthopedic, trauma, maxillofacial, and cardiovascular fields.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-submission and version-linked sensitivity endpoint is promoted; candidate or product-family values were not substituted.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-submission and version-linked specificity endpoint is promoted; candidate or product-family values were not substituted.

Intended-use validation cases

12 cases

  • Endpointvalidation dataset size
  • PopulationOrthopedic, trauma, maxillofacial, and cardiovascular cases
  • Tested versionAxial3D Insight (K232841)
Source

FDA submission-specific verification and validation evidence for K232841

  • DesignFDA 510(k) regulatory decision material and submission-specific verification or validation evidence for K232841; this is regulatory evidence, not an independent clinical effectiveness study.
  • PopulationThe labeled population, anatomy, images, and test materials described in the exact FDA decision material for K232841; a broader clinical population is not established here.
  • Scopeexact submission
  • Tested versionAxial3D Insight (K232841)
  • Samplen=12
  • IndependenceSponsor or vendor study

K232841

The exact FDA material describes a clinical segmentation performance study with 3 radiologists reviewing 12 cases and an intended-use validation study with 9 physicians reviewing 12 cases across orthopedic, trauma, maxillofacial, and cardiovascular fields.

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 exact-release price, license fee, subscription, contract, or implementation cost was established in this review.

Reimbursement and coding
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

CMS coverage-index context was checked, but no product-specific coverage or reimbursement determination is inferred.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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
2026-09-20Last searched
31Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

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 summary, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, 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 510(k) decision material K232841: Axial3D Insight

    U.S. Food and Drug Administration - Published 2023-11-15 - Accessed 2026-09-04

    Scope: identity, productIdentity, 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 medical segmentation family context

    Axial3D - Accessed 2026-09-04

    Scope: productFamilyContext

Research history

  1. K232841 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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