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 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
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.
FDA source Exact FDA submission Checked 2026-09-06
The K261405 modification expands the normative-dataset lower age boundary to 16-17 years; the reviewed summary does not establish a broader care-setting restriction.
FDA source Exact FDA submission Checked 2026-09-06
DICOM-readable atlas visualization, brain-structure segmentation and volumetric quantification information, including normative or longitudinal comparison when used as described in the summary.
FDA source Exact FDA submission Checked 2026-09-06
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
K261405
FDA source Exact FDA submission Checked 2026-08-31
Vendor confirmation Exact FDA submission Checked 2026-09-06
Cloud/on-premise deployment language does not establish formal security controls for an installed configuration.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Trained-user intent does not establish a verified current training program.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
No verified monitoring service was found. Site acceptance should test DICOM input/output, processing failures and clinician review workflow.
Current ANDI family context
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 · checked 2026-09-06
Current ANDI 2.0 family material does not establish feature parity with the K261405 ANDI 2.2 submission.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
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.
FDA source Exact FDA submission Checked 2026-09-06
Reviewed sources checked Exact FDA submission Checked 2026-09-06
No diagnostic sensitivity endpoint was established by the reviewed modification summary.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-06
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.
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 2026-09-06
No public exact-version price or procurement record reviewed.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable CMS policy content reviewed; no coverage conclusion is made.
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
Verify security and privacy controls: Cloud/on-premise deployment language does not establish formal security controls for an installed configuration.
Verify training: Trained-user intent does not establish a verified current training program.
Verify pricing and total cost: No public exact-version price or procurement record reviewed.
Verify reimbursement and coding relevance: No applicable CMS policy content reviewed; no coverage conclusion is made.
Verify local validation and lifecycle monitoring: No verified monitoring service was found. Site acceptance should test DICOM input/output, processing failures and clinician review workflow.
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.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
22Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
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
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