ANDI 2.0

K252298

Imeka Solutions, Inc. · cleared 2025-10-22 · product code QIH · Radiology

FDA 510(k) summary for ANDI 2.0 (K252298)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
2
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“ANDI is software as a medical device (SaMD) that can be deployed on a cloud-based system, or installed on-premises.”
AlgorithmAI-based brain segmentation algorithm
source quote (p.5)
“An optional AI-based segmentation feature enables quantification of the volume of gray matter regions.”
Adaptive (vs locked)No
source quote (p.7)
“The device incorporates a pretrained third-party brain segmentation algorithm as detailed in the SBOM.”
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“Guidance for Industry and FDA Staff – Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 2023”

Validation studies (1)

Standalone

n=71 patients

endpoints: accuracy of the AI-based brain extraction; accuracy and robustness of the brain regions segmentation; overall robustness of the processing pipeline; reproducibility of the brain regions segmentation

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 Device Software Functions, June 2023, Guidance for Industry and FDA Staff – Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 2023

Reported performance (2 observations)

diceas written: “Average Dice coefficients for major subcortical brain structures”stated without valueCI 0.89 to 0.96
source quote (p.8)
“Average Dice coefficients ranged from 0.89 to 0.96 for major subcortical brain structures”
diceas written: “Average Dice coefficients for major cortical brain structures”stated without valueCI 0.79 to 0.93
source quote (p.8)
“and from 0.79 to 0.93 for major cortical brain structures”

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • predicate_cohort_contagion

    K252298 shares predicate K220437 with K250686 (GyriCalc (Version 1.0.0)), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K220437 sibling:K250686

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code QIH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252298