Quantib Brain 1

K153351

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

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

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) 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

  • 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/K153351