Quantib ND

K182564

Quantib BV · cleared 2018-12-27 · 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. The Quantib™ ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyperintensities. Volumetric measurements may be compared to reference centile data. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Quantib™ ND is a software application on top of Myrian®.”
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. For hippocampus segmentation, a slightly different refinement step is used than for other brain structures.
source quote (p.4)
“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. For hippocampus segmentation, a slightly different refinement step is used than for other brain structures.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

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]

standards: ISO 14971, IEC 62304, IEC 62366

Retrospective clinical

n=13 images

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

standards: ISO 14971, IEC 62304, IEC 62366

Retrospective clinical

n=45 images

endpoints: Dice overlap; Absolute difference of the relative volumes

standards: ISO 14971, IEC 62304, IEC 62366

Reported performance (3 observations)

diceas written: “Dice index (Brain)”0.96CI ± 0.01
source quote (p.7)
“Brain A 0.96 ± 0.01”
diceas written: “Dice index (Hippocampus total)”0.84CI ± 0.03
source quote (p.7)
“Hippocampus total B 0.84 ± 0.03”
diceas written: “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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
29
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230772 (decision 2023-04-17) from Quantib BV for a matching device line ("Quantib Prostate") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230772

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K221106 (decision 2022-05-13) from Quantib BV for a matching device line ("Quantib Prostate") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K221106

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K202501 (decision 2020-10-11) from Quantib BV for a matching device line ("Quantib Prostate") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K202501

  • 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

  • …and 23 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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K182564