Icobrain
K192130Icometrix NV · cleared 2019-12-13 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.7)
“During the pre-processing, each scan is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the measurements of the brain structures and abnormalities.”
Validation studies (2)
Retrospective clinical
n=463 cases
endpoints: accuracy of volumes / volume changes; reproducibility of volumes / volume changes
standards: ISO 14971:2007, IEC 62304:2006, IEC 62366:2014, ISO 12052:2006, CFR 21 part 820, ISO 13485:2016
Retrospective clinical
n=618 cases
endpoints: accuracy of volumes / volume changes; reproducibility of volumes / volume changes
standards: ISO 14971:2007, IEC 62304:2006, IEC 62366:2014, ISO 12052:2006, CFR 21 part 820, ISO 13485:2016
Reported performance (2 observations)
source quote (p.10)
“the intraclass correlation coefficient was 0.90.”
source quote (p.10)
“the intraclass correlation coefficient was 0.93.”
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) 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
- 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).