icobrain

K181939

icometrix NV · cleared 2018-11-06 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images.”

Algorithmclassical machine learning and deep learning (supervised voxel classification with Convolutional Neural Networks)

source quote (p.7)

“segmentation by classical machine learning and deep learning (in our case supervised voxel classication with Convolutional Neural Networks)”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=544 cases

endpoints: Accuracy of measurements for lesions; Accuracy of measurements for basal cisterns; Accuracy of measurements for lateral ventricles; Accuracy of measurements for midline shift; Accuracy of measurements for whole brain volumes

Bench

n=544 cases

endpoints: Reproducibility of measurements on CT images

Reported performance (1 observation)

agreement_kappaas written: “Intraclass correlation coefficient”0.94

source quote (p.8)

“the intraclass correlation coefficient was 0.94.”

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) K240712 (decision 2024-11-07) from icometrix NV for a matching device line ("icobrain aria") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240712
re_clearance
The FDA AI/ML device list shows a newer 510(k) K192962 (decision 2020-02-28) from Icometrix NV for a matching device line ("icobrain-ctp") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K192962
re_clearance
The FDA AI/ML device list shows a newer 510(k) K192130 (decision 2019-12-13) from Icometrix NV for a matching device line ("Icobrain") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K192130
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).