Quantib ND

K213737

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

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 (4)

Retrospective clinical

n=33 images

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

standards: ISO 14971, IEC 62304, IEC 62366

Retrospective clinical

n=89 images

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

Retrospective clinical

n=13 images

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

Retrospective clinical

n=45 images

endpoints: Dice overlap; Absolute difference of the relative volumes

Reported performance (22 observations)

diceas written: “Brain Dice index”0.96CI ± 0.01
source quote (p.7)
“Brain A 0.96 ± 0.01”
diceas written: “CSF Dice index”0.78CI ± 0.05
source quote (p.7)
“CSF A 0.78 ± 0.05”
diceas written: “ICV Dice index”0.98CI ± 0.00
source quote (p.7)
“ICV A 0.98 ± 0.00”
diceas written: “Hippocampus total Dice index”0.84CI ± 0.03
source quote (p.7)
“Hippocampus total B 0.84 ± 0.03”
diceas written: “Hippocampus right Dice index”0.84CI ± 0.03
source quote (p.7)
“Hippocampus right 0.84 ± 0.03”
diceas written: “Hippocampus left Dice index”0.84CI ± 0.04
source quote (p.7)
“Hippocampus left 0.84 ± 0.04”
diceas written: “Frontal lobe total Dice index”0.95CI ± 0.01
source quote (p.8)
“Frontal lobe total C 0.95 ± 0.01”
diceas written: “Frontal lobe right Dice index”0.94CI ± 0.02
source quote (p.8)
“Frontal lobe right 0.94 ± 0.02”
diceas written: “Frontal lobe left Dice index”0.94CI ± 0.02
source quote (p.8)
“Frontal lobe left 0.94 ± 0.02”
diceas written: “Occipital lobe total Dice index”0.89CI ± 0.03
source quote (p.8)
“Occipital lobe total C 0.89 ± 0.03”
diceas written: “Occipital lobe right Dice index”0.88CI ± 0.04
source quote (p.8)
“Occipital lobe right 0.88 ± 0.04”
diceas written: “Occipital lobe left Dice index”0.88CI ± 0.03
source quote (p.8)
“Occipital lobe left 0.88 ± 0.03”
diceas written: “Parietal lobe total Dice index”0.89CI ± 0.03
source quote (p.8)
“Parietal lobe total C 0.89 ± 0.03”
diceas written: “Parietal lobe right Dice index”0.88CI ± 0.04
source quote (p.8)
“Parietal lobe right 0.88 ± 0.04”
diceas written: “Parietal lobe left Dice index”0.88CI ± 0.03
source quote (p.8)
“Parietal lobe left 0.88 ± 0.03”
diceas written: “Temporal lobe total Dice index”0.91CI ± 0.02
source quote (p.8)
“Temporal lobe total C 0.91 ± 0.02”
diceas written: “Temporal lobe right Dice index”0.91CI ± 0.02
source quote (p.8)
“Temporal lobe right 0.91 ± 0.02”
diceas written: “Temporal lobe left Dice index”0.9CI ± 0.03
source quote (p.8)
“Temporal lobe left 0.90 ± 0.03”
diceas written: “Cerebellum total Dice index”0.99CI ± 0.00
source quote (p.8)
“Cerebellum total C 0.99 ± 0.00”
diceas written: “Cerebellum right Dice index”0.97CI ± 0.01
source quote (p.8)
“Cerebellum right 0.97 ± 0.01”
diceas written: “Cerebellum left Dice index”0.97CI ± 0.01
source quote (p.8)
“Cerebellum left 0.97 ± 0.01”
diceas written: “WMH Dice overlap”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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
drift signals on this device
  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98428

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98137

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97993

  • …and 20 more.

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K213737