Quantib Brain 1
K153351QUANTIB BV · cleared 2016-06-17 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
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.”
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. Histogram analysis and trained classifiers are used in combination with atlas-based tissue segmentation to improve the accuracy and specificity of WMH segmentation.”
Validation studies (3)
Bench
sample size not stated
standards: ISO 14971 - Medical devices - Application of risk management to medical devices, IEC 62304 – Medical device software – Software life cycle processes
Retrospective clinical
n=33 images
endpoints: Dice index; Absolute difference of the relative volumes
Retrospective clinical
n=30 images
endpoints: Dice overlap; Absolute difference of the relative volumes
Reported performance (5 observations)
source quote (p.7)
“CSF 0.78 ± 0.05”
source quote (p.7)
“GM 0.83 ± 0.02”
source quote (p.7)
“WM 0.86 ± 0.02”
source quote (p.7)
“ICV 0.97 ± 0.01”
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
- 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). 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).