Quantib Brain 1.2

K163013

Quantib BV · cleared 2017-01-06 · 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 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. A straight forward algorithm based on overlapping voxels was added for WMH longitudinal labeling.

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. To help the user in distinguishing between consistent, new and disappearing WMH, a straight forward algorithm based on overlapping voxels was added to the software for which the performance was assessed.”

Adaptive (vs locked)No

source quote (p.5)

“This modification did not require changes in the underlying automated segmentation algorithms and all extra information is derived from the cross sectional measurements. To help the user in distinguishing between consistent, new and disappearing WMH, a straight forward algorithm based on overlapping voxels was added to the software for which the performance was assessed.”

PCCPFDA source did not state this

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=12 patients

endpoints: Agreement of automatic WMH labeling with manual labeling

standards: ISO 14971, IEC 62304, IEC 62366

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
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
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
…and 22 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).