Quantib Brain

K173939

Quantib BV · cleared 2018-03-09 · 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.”

AlgorithmThe algorithm uses a different voting mechanism for brain volumetry and a classifier with extended features for white matter hyperintensities segmentation.

source quote (p.5)

“To improve the ICV results, a different voting mechanism is applied. In the White Matter Hyperintensities segmentation algorithm of Quantib Brain 1.3 we have implemented a different type of classifier to classify the set of candidate lesions. To improve the algorithm performance, we have extended the set of features used in the classifier.”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=33 images

endpoints: Dice index; Absolute difference of the relative volumes

standards: ISO 14971, IEC 62304

Retrospective clinical

n=45 images

endpoints: Dice overlap; Absolute difference of the relative volumes

standards: ISO 14971, IEC 62304

Reported performance (5 observations)

diceas written: “CSF Dice index”0.78CI ± 0.05

source quote (p.7)

“CSF 0.78 ± 0.05”

diceas written: “GM Dice index”0.84CI ± 0.02

source quote (p.7)

“GM 0.84 ± 0.02”

diceas written: “WM Dice index”0.86CI ± 0.02

source quote (p.7)

“WM 0.86 ± 0.02”

diceas written: “ICV Dice index”0.97CI ± 0.00

source quote (p.7)

“ICV 0.97 ± 0.00”

diceas written: “WMH Average 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 (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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

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
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
…and 21 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).