Icobrain

K192130

Icometrix NV · cleared 2019-12-13 · product code LLZ · Radiology

FDA 510(k) summary for Icobrain (K192130)

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
2
Cited predicates
3
Performance observations
2
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Medical Image Processing Software”
AlgorithmFDA source did not state this
Adaptive (vs locked)No
source quote (p.10)
“The changes made in icobrain compared to the original device do not affect the safety of the device. This conclusion is based on: Failure mode and effects analysis on the added functionality. Risk category classification of new software components.”
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=463 patients

endpoints: accuracy; reproducibility

standards: ISO 14971:2007 Medical devices - Application of risk management to medical devices, IEC 62304:2006 Medical device software - Software life-cycle processes, IEC 62366:2014 Medical devices - Application of usability engineering to medical devices, ISO 12052:2006 Digital imaging and communication in medicine (DICOM), CFR 21 part 820 Quality System Regulation for Medical Devices, ISO 13485:2016 Medical devices - Quality management systems

Retrospective clinical

n=618 patients

endpoints: accuracy; reproducibility

standards: ISO 14971:2007 Medical devices - Application of risk management to medical devices, IEC 62304:2006 Medical device software - Software life-cycle processes, IEC 62366:2014 Medical devices - Application of usability engineering to medical devices, ISO 12052:2006 Digital imaging and communication in medicine (DICOM), CFR 21 part 820 Quality System Regulation for Medical Devices, ISO 13485:2016 Medical devices - Quality management systems

Reported performance (2 observations)

agreement_kappaas written: “Intraclass correlation coefficient (MR)”0.9
source quote (p.10)
“the intraclass correlation coefficient was 0.90.”
agreement_kappaas written: “Intraclass correlation coefficient (CT)”0.93
source quote (p.10)
“the intraclass correlation coefficient was 0.93.”

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
33
drift signals on this device
  • predicate_cohort_contagion

    K192130 shares predicate K181939 with K211222 (qER-Quant), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K181939 sibling:K211222

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240712 (decision 2024-11-07) from icometrix NV for a matching device line ("icobrain aria") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240712

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K192962 (decision 2020-02-28) from Icometrix NV for a matching device line ("icobrain-ctp") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K192962

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • …and 27 more.

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 2026-09-02.

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 LLZ

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/K192130