Radiology AI Directory

FDA-cleared profile

LumiNE US; Lumi

Augmedit B.V.

LumiNE converts adult CT or contrast-enhanced T1 MR images into reviewed three-dimensional models and displays two- and three-dimensional images in a browser or Microsoft HoloLens 2 for preoperative planning, not diagnosis.

Radiological images; modality varies or is not specified in FDA list workflow
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
LumiNE converts adult CT or contrast-enhanced T1 MR images into reviewed three-dimensional models and displays two- and three-dimensional images in a browser or Microsoft HoloLens 2 for preoperative planning, not diagnosis.
FDA source Exact FDA submission Checked 2026-09-03
Intended users
Neurosurgeons, neurosurgical residents, and hospital-qualified medical professionals preparing imaging for surgeons.
FDA source Exact FDA submission Checked 2026-09-03
Care setting and population
Preoperative planning environments for adults aged 22 years or older.
FDA source Exact FDA submission Checked 2026-09-03
Workflow role
Preoperative CT or MR segmentation, 3D model review, and mixed-reality visualization.
Public source Exact FDA submission Checked 2026-09-03
Required input
Adult CT or contrast-enhanced T1 MR DICOM images; STL models can be associated with the source scan in supported workflows.
FDA source Exact FDA submission Checked 2026-09-03
Output and human action
Reviewed 3D models of skin, brain, tumor, and ventricles plus 2D/3D browser or HoloLens visualization.
FDA source Exact FDA submission Checked 2026-09-03
Limitations
Not for diagnosis. MR tumor segmentation is restricted to a single previously diagnosed contrast-enhancing intracranial tumor from 2-100 cc and 15-75 mm; multiple lesions and tumors outside those bounds were not adequately validated.
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
K240094
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 2026-09-03
Anatomy
Brain
FDA source Exact FDA submission Checked 2026-09-03
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2024-09-10
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
DICOM and supported STL ingestion with browser and HoloLens 2 visualization; test scanners, DICOM variants, dimensional fidelity, latency, and export or revision behavior.
Public source Exact FDA submission Checked 2026-09-03
Deployment and data flow
Secure cloud storage and browser-based viewer with optional Microsoft HoloLens 2, as described in K240094.
Public source Exact FDA submission Checked 2026-09-03
Security and privacy
K240094 describes a secure cloud environment and anonymizer. Obtain current encryption, identity, audit, retention, support-access, backup, data-residency, and incident-response details.
FDA source Exact FDA submission Checked 2026-09-03

Confirm the controls against the exact contracted architecture and release.

Training and support
Only neurosurgeons, neurosurgical residents, and hospital-qualified medical professionals preparing imaging for surgeons. should operate or interpret the system. 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 and model 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 the limits that matter for this product: Not for diagnosis. MR tumor segmentation is restricted to a single previously diagnosed contrast-enhancing intracranial tumor from 2-100 cc and 15-75 mm; multiple lesions and tumors outside those bounds were not adequately validated.
Public source Exact FDA submission Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K240094 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

DICOM and supported STL ingestion with browser and HoloLens 2 visualization; test scanners, DICOM variants, dimensional fidelity, latency, and export or revision behavior.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

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. Not for diagnosis. MR tumor segmentation is restricted to a single previously diagnosed contrast-enhancing intracranial tumor from 2-100 cc and 15-75 mm; multiple lesions and tumors outside those bounds were not adequately validated.

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

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model 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 the limits that matter for this product: Not for diagnosis. MR tumor segmentation is restricted to a single previously diagnosed contrast-enhancing intracranial tumor from 2-100 cc and 15-75 mm; multiple lesions and tumors outside those bounds were not adequately validated.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
Exact-submission U.S. testing used independent expert-truthed MR cases. Median Dice and 95% Hausdorff results met prespecified criteria for brain, skin, tumor, and ventricles; subgroup findings directly produced the single-tumor size limits. A later phantom crossover study is product-family workflow evidence only.
Public 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 applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Brain median Dice

0.96 DSC

Brain segmentation in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Skin median Dice

0.99 DSC

Skin segmentation in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Tumor median Dice

0.93 DSC

Single eligible intracranial tumor segmentation in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Ventricle median Dice

0.89 DSC

Ventricle segmentation in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Brain median HD95

5.88 mm

Brain boundary distance in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Skin median HD95

3.36 mm

Skin boundary distance in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Tumor median HD95

2.85 mm

Tumor boundary distance in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

Ventricle median HD95

1.93 mm

Ventricle boundary distance in LumiNE US; Lumi.

Tested version: LumiNE US / Lumi cleared in K240094
Source

K240094 FDA performance package for LumiNE US; Lumi

Manufacturer independent U.S. MR segmentation validation against consensus reference standards from three U.S. neurosurgeons · Adults with contrast-enhanced T1 brain MRI and eligible known intracranial tumors

exact submission · Tested version: LumiNE US / Lumi cleared in K240094 · Sponsor or vendor study

K240094

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

Mixed-reality preoperative planning with Lumi

Phantom crossover evaluation · Simulated neurosurgical planning tasks

product family · Tested version: Lumi product family; exact K240094 build not established · Independent study

PMC12743098

Product-family workflow evidence in a simulated setting, not clinical outcome evidence.

Source

Economics and lifecycle

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, enabled features, 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 device within the applicable imaging 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.

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 K240094 by exact submission identifier.
Public source Exact FDA submission Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal 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.

Human reviewedStatus
2026-09-04Last searched
24Fields reviewed
9Source classes checked
20Unreviewed PubMed leads
10Unreviewed trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 10 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, vendor product page, peer reviewed publication, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-03.

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