icobrain-ctp
K192962Icometrix NV · cleared 2020-02-28 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.”
source quote (p.6)
“The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow).”
Validation studies (2)
Bench
sample size not stated
endpoints: Correlation, p90 absolute difference and mean relative difference between the output of icobrain ctp device and the ground truth values were calculated, and compared to preestablished performance goals based on academic literature.; The acceptance criteria were set on the correlation, the percentile 90 absolute difference and the mean relative difference between the ground truth and the estimated values.
Retrospective clinical
sample size not stated
endpoints: CBF and Tmax abnormality volumes were compared to the corresponding volumes from the reference device. The acceptance criteria were set on the percentile 90 of the volume differences for both the CBF abnormality and the Tmax abnormality.; unbiased CBF abnormality volume was compared to ground truth volumes from manually delineated DWI images. The acceptance criteria were set on the percentile 90 of the volume differences.; region of interest (ROI) volume was compared to ground truth volumes from manually annotated ROI. The acceptance criteria were set on the percentile 90 of the volume differences.; Reproducibility was tested on test and retest CT perfusion images. The retest images were produced by simulating patient motion on the test images. The acceptance criteria were set on the percentile 90 of the volume differences for both the CBF abnormality and the Tmax abnormality.
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97993
- …and 20 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).