Quantib ND

K213737

Quantib B.V. · cleared 2022-01-14 · product code LLZ · Radiology

FDA 510(k) summary for Quantib ND (K213737)

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
22
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 ND 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.”
AlgorithmThe segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments.
source quote (p.5)
“The segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments.”
Adaptive (vs locked)No
source quote (p.6)
“No significant performance differences are expected and observed since no changes have been made to algorithms and their implementation.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Cybersecurity and vulnerability analysis”

Validation studies (2)

Retrospective clinical

n=89 images

endpoints: Dice index; Absolute difference of the relative volumes

standards: ISO 14971, IEC 62304, IEC 62366

Retrospective clinical

n=45 images

endpoints: Dice overlap; Absolute difference of the relative volumes

Reported performance (22 observations)

diceas written: “Dice index (Brain)”0.96CI ± 0.01
source quote (p.7)
“Brain A 0.96 ± 0.01 1.63 ± 1.06”
diceas written: “Dice index (CSF)”0.78CI ± 0.05
source quote (p.7)
“CSF A 0.78 ± 0.05 1.67 ± 1.06”
diceas written: “Dice index (ICV)”0.98CI ± 0.00
source quote (p.7)
“ICV A 0.98 ± 0.00 -”
diceas written: “Dice index (Hippocampus total)”0.84CI ± 0.03
source quote (p.7)
“Hippocampus total B 0.84 ± 0.03 0.03 ± 0.02”
diceas written: “Dice index (Hippocampus right)”0.84CI ± 0.03
source quote (p.7)
“Hippocampus right 0.84 ± 0.03 0.01 ± 0.01”
diceas written: “Dice index (Hippocampus left)”0.84CI ± 0.04
source quote (p.7)
“Hippocampus left 0.84 ± 0.04 0.01 ± 0.01”
diceas written: “Dice index (Frontal lobe total)”0.95CI ± 0.01
source quote (p.8)
“Frontal lobe total C 0.95 ± 0.01 1.21 ± 1.22”
diceas written: “Dice index (Frontal lobe right)”0.94CI ± 0.02
source quote (p.8)
“Frontal lobe right 0.94 ± 0.02 0.76 ± 0.58”
diceas written: “Dice index (Frontal lobe left)”0.94CI ± 0.02
source quote (p.8)
“Frontal lobe left 0.94 ± 0.02 0.60 ± 0.67”
diceas written: “Dice index (Occipital lobe total)”0.89CI ± 0.03
source quote (p.8)
“Occipital lobe total C 0.89 ± 0.03 0.75 ± 0.83”
diceas written: “Dice index (Occipital lobe right)”0.88CI ± 0.04
source quote (p.8)
“Occipital lobe right 0.88 ± 0.04 0.54 ± 0.48”
diceas written: “Dice index (Occipital lobe left)”0.88CI ± 0.03
source quote (p.8)
“Occipital lobe left 0.88 ± 0.03 0.44 ± 0.36”
diceas written: “Dice index (Parietal lobe total)”0.89CI ± 0.03
source quote (p.8)
“Parietal lobe total C 0.89 ± 0.03 1.21 ± 1.31”
diceas written: “Dice index (Parietal lobe right)”0.88CI ± 0.04
source quote (p.8)
“Parietal lobe right 0.88 ± 0.04 0.73 ± 0.76”
diceas written: “Dice index (Parietal lobe left)”0.88CI ± 0.03
source quote (p.8)
“Parietal lobe left 0.88 ± 0.03 0.64 ± 0.67”
diceas written: “Dice index (Temporal lobe total)”0.91CI ± 0.02
source quote (p.8)
“Temporal lobe total C 0.91 ± 0.02 0.87 ± 0.74”
diceas written: “Dice index (Temporal lobe right)”0.91CI ± 0.02
source quote (p.8)
“Temporal lobe right 0.91 ± 0.02 0.46 ± 0.33”
diceas written: “Dice index (Temporal lobe left)”0.9CI ± 0.03
source quote (p.8)
“Temporal lobe left 0.90 ± 0.03 0.47 ± 0.46”
diceas written: “Dice index (Cerebellum total)”0.99CI ± 0.00
source quote (p.8)
“Cerebellum total C 0.99 ± 0.00 0.19 ± 0.13”
diceas written: “Dice index (Cerebellum right)”0.97CI ± 0.01
source quote (p.8)
“Cerebellum right 0.97 ± 0.01 0.12 ± 0.07”
diceas written: “Dice index (Cerebellum left)”0.97CI ± 0.01
source quote (p.8)
“Cerebellum left 0.97 ± 0.01 0.17 ± 0.11”
diceas written: “Average Dice overlap (WMHs)”0.61CI ± 0.13
source quote (p.8)
“The average Dice overlap between the manual segmentations and Quantib ND segmentations was 0.61 ± 0.13 (over all cases).”

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
30
drift signals on this device
  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • …and 24 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.

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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/K213737