Quantib Brain 1

K153351

QUANTIB BV · cleared 2016-06-17 · product code LLZ · Radiology

FDA 510(k) summary for Quantib Brain 1 (K153351)

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
1
Performance observations
5
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Quantib™ Brain is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images.”
Algorithmatlas-based segmentation, histogram analysis and trained classifiers
source quote (p.6)
“Atlas-based segmentation is the technological principle for both devices. ... Histogram analysis and trained classifiers are used in combination with atlas-based tissue segmentation to improve the accuracy and specificity of WMH segmentation.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=33 images

endpoints: Dice index; Absolute difference of the relative volumes [pp]

standards: ISO 14971 - Medical devices - Application of risk management to medical devices, IEC 62304 – Medical device software – Software life cycle processes

Retrospective clinical

n=30 images

endpoints: Dice overlap; Absolute difference of the relative volumes (for WMHs)

standards: ISO 14971 - Medical devices - Application of risk management to medical devices, IEC 62304 – Medical device software – Software life cycle processes

Reported performance (5 observations)

diceas written: “CSF Dice index”0.78CI ± 0.05
source quote (p.7)
“0.78 ± 0.05”
diceas written: “GM Dice index”0.83CI ± 0.02
source quote (p.7)
“0.83 ± 0.02”
diceas written: “WM Dice index”0.86CI ± 0.02
source quote (p.7)
“0.86 ± 0.02”
diceas written: “ICV Dice index”0.97CI ± 0.01
source quote (p.7)
“0.97 ± 0.01”
diceas written: “WMHs Dice overlap”0.61CI ± 0.13
source quote (p.7)
“The average Dice overlap between the manual segmentations and Quantib™ Brain segmentations was 0.61 ± 0.13.”

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
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K182564 (decision 2018-12-27) from Quantib BV for a matching device line ("Quantib ND") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K182564

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K173939 (decision 2018-03-09) from Quantib BV for a matching device line ("Quantib Brain") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K173939

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K163013 (decision 2017-01-06) from Quantib BV for a matching device line ("Quantib Brain 1.2") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K163013

  • 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

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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/K153351