ANDI
K230913Imeka Solutions, Inc. · cleared 2023-07-25 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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. 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.”
source quote (p.4)
“The device processes diffusion weighted images using local (on a per-voxel basis) and global (for the whole brain) reconstruction algorithms, respectively called modeling, tractography, and white matter bundling, to map microstructural properties of the white matter. Performance tests were conducted to assess the measured end points, AI-based brain extraction, and robustness of the processing pipeline. 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.”
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, ANSI/AAMI/IEC 62304:2006/A1:2016, 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
- 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). 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).