API-to-RIS/PACS report workflow
The exact submission describes an API for image input and report output, NIfTI input, and a DICOM encapsulated PDF report supported by RIS/PACS.
exact submission · checked 2026-09-07FDA-cleared profile
ANDI
Imeka Solutions, Inc.
ANDI processes diffusion-weighted MRI with auxiliary T1 imaging to create 3D white-matter tract maps and microstructure reports for trained medical professionals as adjunctive measurement information, not diagnosis.
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
- ANDI processes diffusion-weighted MRI with auxiliary T1 imaging to create 3D white-matter tract maps and microstructure reports for trained medical professionals as adjunctive measurement information, not diagnosis.
- Intended users
- Medical professionals, including neurologists and radiologists; trained professionals make the final decision.
- Care setting and population
- Clinical neuroimaging for trained medical professionals such as neurologists and radiologists; the output is adjunctive to standard-of-care evaluation.
- Workflow role
- Diffusion MRI tractography, white-matter microstructure measurement, and adjunctive visualization support
- Required input
- Diffusion-weighted MRI with T1-weighted images as auxiliary input; the exact comparison describes NIfTI image input and an API-based interface, with reversed-phase-encoded B=0 as an optional input. The exact acquisition protocol was not established.
- Output and human action
- 3D white-matter tract maps and a CSD-based microstructure report providing reference information for comparison with a control population and, optionally, longitudinal comparison; the subject device output is a DICOM encapsulated PDF report supported by RIS/PACS.
- Limitations
- ANDI measures white-matter tracts only and does not predict, diagnose, or interpret brain health; it is adjunctive and not a diagnostic aid. A physician must review all clinical information. The exact packet distinguishes NIfTI/API input from DICOM-compliant report output, so local interface compatibility requires confirmation.
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 exact submission describes API-based image input and report output, NIfTI input, and DICOM encapsulated PDF output supported by RIS/PACS; this is not evidence that the subject device accepts DICOM images directly as input.
- Deployment and data flow
- Cloud-based image-processing software
The FDA comparison describes both subject and predicate as cloud-based; current hosting region, retention, and data-flow controls were not separately established.
- Security and privacy
- Vendor documentation pending
The reviewed sources do not establish a scoped security audit, certification, or control set.
- Training and support
- Vendor documentation pending
Training, credentialing, and implementation support terms were not established.
- Monitoring and change control
- Vendor documentation pending
Current post-deployment monitoring and change-control practices were not established.
Current ANDI quantitative DTI workflow
Imeka's official ANDI page describes a current family workflow from raw diffusion data to a quantitative report, including automated tract analysis, normative comparisons, longitudinal views, and a secure cloud environment; this current family description is not promoted to exact K230913 version performance or security evidence.
product family · checked 2026-09-07Current family page context only; exact-version and local interface compatibility require confirmation.
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 FDA describes non-clinical performance testing of measured endpoints, AI brain extraction, processing-pipeline robustness, and report content/structure; it states that no clinical studies were considered necessary or performed.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
ANDI non-clinical performance and report validation
- DesignNon-clinical software performance, robustness, and report-structure validation
- PopulationPredefined software test protocols covering measured endpoints, AI brain extraction, processing-pipeline robustness, and a summative report evaluation; sample counts were not stated in the reviewed summary.
- Scopeexact submission
- Tested versionANDI submitted in K230913; build not stated
- IndependenceIndependence not established
K230913
The FDA states that no clinical studies were considered necessary or performed. No independent investigators or sponsorship were established.
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 amount, range, currency, geography, or contract term was established.
- Reimbursement and coding
- Research pending
No payer or CMS policy review was performed in this worker cohort.
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
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
- Verify security and privacy controls: The reviewed sources do not establish a scoped security audit, certification, or control set.
- Verify training: Training, credentialing, and implementation support terms were not established.
- Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
- Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
- Verify local validation and lifecycle monitoring: Current post-deployment monitoring and change-control practices were not established.
- Verify recalls and postmarket safety signals: 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.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
10Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed, ClinicalTrials.gov, and exact-submission recall metadata candidates were screened by identifier and count. The records were not treated as a full paper, trial, or postmarket review. The current discovery snapshot contains 20 PubMed and 10 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, literature index, trial registry, 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
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FDA 510(k) K230913: ANDI
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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ANDI model card (K230913)
Scope: purpose, modality, intendedUsers, output, limitations, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
ANDI quantitative diffusion MRI workflow
Scope: productFamily, clinicalWorkflow, reports, implementationCapabilities
Research history
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K230913 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
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