Cloud or on-premises SaaS processing
The cleared submission describes cloud or on-premises SaaS processing without a GUI and generation of quantitative brain MRI reports.
exact submission · checked 2026-09-07FDA-cleared profile
ANDI 2.0
Imeka Solutions, Inc.
Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical decision.
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
- Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical decision.
- Intended users
- Radiologists, neurologists and other qualified healthcare professionals interpreting brain MRI.
- Care setting and population
- Healthcare neuroimaging services using supported brain MRI protocols.
- Workflow role
- Quantitative visualization and segmentation aid for physician review; it does not independently diagnose or predict disease.
- Required input
- DICOM brain MR image sets including DWI and T1 sequences within the supported acquisition and scanner scope.
- Output and human action
- Atlas-assisted visualization, automated segmentation and volumes, normative comparison and longitudinal reports for white-matter microstructure and optional gray-matter volumetry.
- Limitations
- ANDI 2.0 is adjunctive and does not diagnose or predict disease. All results require physician review. FDA validation used defined MRI sequences, sites, manufacturers and reference methods; applicability outside those conditions is not established here.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The FDA summary describes cloud or on-premises SaaS processing without a GUI and generation of reports for clinical review; local DICOM routing and viewer configuration require confirmation.
- Deployment and data flow
- Cloud or on-premises SaaS deployment described in the submission; no standalone GUI is described.
- Security and privacy
- Imeka describes ANDI as a secure-cloud workflow for automated brain MRI reporting.
This family statement does not establish exact K252298 controls, retention, certification or a site-specific security assessment.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Automated MRI report workflow
Imeka describes ANDI as a secure-cloud workflow with a 5-8 minute single-shell sequence, support for MRI manufacturers at 1.5T or 3T, 33 fiber-tract segmentations, normative comparison and longitudinal reports.
product family · checked 2026-09-06Family page capabilities do not establish exact K252298 availability, hosting contract or performance.
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
- FDA validation included 747 independent validation subjects across sites and manufacturers. The detailed accuracy cohort included 71 subjects with healthy, MS, Parkinson, Alzheimer and MCI cases; subcortical Dice averaged 0.89-0.96 and cortical Dice 0.79-0.93. Reproducibility testing in 59 subjects reported mean absolute volume difference 2.1% and individual differences 1.2%-3.9%.
- Reported sensitivity
- Not established in reviewed sources
The cleared endpoints are segmentation and volumetric agreement measures, not disease-detection sensitivity.
- Reported specificity
- Not established in reviewed sources
The cleared endpoints are segmentation and volumetric agreement measures, not disease-detection specificity.
Subcortical Dice lower bound
0.89 Dice coefficient, lower endpoint of reported range
- EndpointSegmentation overlap
- Population71-subject accuracy cohort within the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
Subcortical Dice upper bound
0.96 Dice coefficient, upper endpoint of reported range
- EndpointSegmentation overlap
- Population71-subject accuracy cohort within the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
Cortical Dice lower bound
0.79 Dice coefficient, lower endpoint of reported range
- EndpointSegmentation overlap
- Population71-subject accuracy cohort within the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
Cortical Dice upper bound
0.93 Dice coefficient, upper endpoint of reported range
- EndpointSegmentation overlap
- Population71-subject accuracy cohort within the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
Reproducibility mean absolute volume difference
2.1 percent
- EndpointMean absolute volume difference
- Population59-subject reproducibility cohort in the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
Reproducibility individual difference lower bound
1.2 percent, lower endpoint of reported range
- EndpointIndividual absolute volume difference
- Population59-subject reproducibility cohort in the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
Reproducibility individual difference upper bound
3.9 percent, upper endpoint of reported range
- EndpointIndividual absolute volume difference
- Population59-subject reproducibility cohort in the FDA ANDI validation
- Tested versionANDI 2.0 configuration submitted in K252298
ANDI 2.0 segmentation accuracy validation
- DesignIndependent multi-site and multi-manufacturer validation with normative and disease cohorts; reference segmentation used FreeSurfer, expert review and three board-certified neuroradiologists
- Population747 independent validation subjects; detailed accuracy cohort 71 subjects including healthy, MS, Parkinson, Alzheimer and MCI cases
- Scopeexact submission
- Tested versionANDI 2.0 configuration submitted in K252298
- Samplen=747
- IndependenceSponsor or vendor study
K252298
The 71-subject detailed cohort included 35 women and 36 men, ages 18-86, with the disease mix stated in the FDA summary.
ANDI 2.0 reproducibility validation
- DesignRepeatability/reproducibility evaluation described in the FDA 510(k) summary
- Population59-subject repeatability cohort across supported MRI conditions
- Scopeexact submission
- Tested versionANDI 2.0 configuration submitted in K252298
- Samplen=59
- IndependenceSponsor or vendor study
K252298
FDA reports mean absolute volume difference 2.1% and individual differences 1.2%-3.9%.
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
- Vendor documentation pending
No public price or quote for ANDI 2.0 was reviewed.
- Reimbursement and coding
- Research pending
Payer policy research was not part of this worker's scope.
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
The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: No public price or quote for ANDI 2.0 was reviewed.
- Verify reimbursement and coding relevance: Payer policy research was not part of this worker's scope.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
22Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, acr ai central product, vendor product page, vendor announcement, stored candidate metadata, 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
-
FDA 510(k) K252298: ANDI 2.0
Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, evidenceMetrics, evidenceStudies
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
ANDI 2.0 model card (K252298)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
Get to know ANDI
Scope: productFamilyContext, clinicalUse, implementationCapabilities
-
Imeka receives FDA 510(k) clearance for ANDI 2.0
Scope: productVersion, productFamilyContext
Research history
-
K252298 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
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