FDA-cleared profile
Imeka Solutions, Inc.
Authorized purpose: ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained medical professionals; it does not predict, diagnose or interpret brain health.
Product overview
Authorized purpose: ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained medical professionals; it does not predict, diagnose or interpret brain health.
Overview status: Source-reviewed overview
Clinical role: ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained medical professionals; it does not predict, diagnose or interpret brain health.
Evidence from the reviewed source record: K261405 is a modification expanding the normative dataset age range. Its reviewed FDA evidence does not include a new clinical study or diagnostic-performance endpoint.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Actual site architecture and cloud region require vendor/site confirmation.
Cloud/on-premise deployment language does not establish formal security controls for an installed configuration.
Trained-user intent does not establish a verified current training program.
No verified monitoring service was found. Site acceptance should test DICOM input/output, processing failures and clinician review workflow.
Imeka's current news page describes ANDI 2.0 as adding brain volumetry to the product family and describes the product as quantitative brain imaging software.
product family ยท checked 2026-09-06Current ANDI 2.0 family material does not establish feature parity with the K261405 ANDI 2.2 submission.
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.
No diagnostic sensitivity endpoint was established by the reviewed modification summary.
No diagnostic specificity endpoint was established by the reviewed modification summary.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public exact-version price or procurement record reviewed.
No applicable CMS policy content reviewed; no coverage conclusion is made.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Stored PubMed and ClinicalTrials candidate metadata snapshots were screened; both arrays were empty. No candidate 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, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, clinicalUse, modality, anatomy, implementationCapabilities, evidenceStudies
Scope: regulatoryIdentity, modalityContext
Scope: intendedUsers, careSetting, output, integration, anatomy, implementationCapabilities
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, currentCommercialContext
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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