ANDI

K230913

Imeka Solutions, Inc. · cleared 2023-07-25 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“ANDI is quantitative imaging software that extracts features from medical images to provide adjunctive information for use with the complete standard of care evaluation of the patient.”
Algorithmcloud-based image processing software that apply an algorithm for modeling diffusion data and generating tractography (whole brain CSD tractography) reports for clinicians to use in planning and visualization. CSD is the underlying diffusion modeling technique used by a tractography process to reconstruct white matter pathways. ANDI uses a proprietary white matter bundles atlas defined by 3D models to segment the major white matter pathways from the subject's tractogram.
source quote (p.5)
“Both devices are cloud-based image processing software that apply an algorithm for modeling diffusion data and generating tractography (whole brain CSD tractography) reports for clinicians to use in planning and visualization. Both devices accept similar inputs, T1 and multi-directional diffusion weighted images (DWI), to process MRI information and output a report using CSD as the underlying diffusion modeling technique used by a tractography process to reconstruct white matter pathways. The predicate utilizes the Glasser atlas, which applies surfacic definitions delineating 180 areas per hemisphere bounded by sharp changes in cortical architecture, function, connectivity, and/or topography. In contrast, ANDI uses a proprietary white matter bundles atlas defined by 3D models to segment the major white matter pathways from the subject's tractogram.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: measured end points; AI-based brain extraction; robustness of the processing pipeline; content and structure of the ANDI report

standards: ISO 14971:2019, Medical Devices – Application of Risk Management to Medical Devices, ANSI/AAMI/IEC 62304:2006/A1:2016, Medical Device Software - Software Life Cycle Processes, Digital Imaging and Communications in Medicine (DICOM) Set (NEMA PS 3.1 - 3.20), Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, November 2021

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252298 (decision 2025-10-22) from Imeka Solutions, Inc. for a matching device line ("ANDI 2.0") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252298

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230913