Neuro Insight V1.0

K243681

Olea Medical S.A.S. · cleared 2025-07-23 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Neuro Insight V1.0 is an image processing solution.”

Algorithm3D deep learning algorithm (3D U-Net architecture)

source quote (p.8)

“Neuro Insight V1.0 uses a brain extraction tool (BET) based on a 3D deep learning algorithm before DSC perfusion maps computation, while Olea Sphere® V3.0 uses thresholds based on a histogram analysis of the MR images. For more information about this deep learning testing and validation process please refer to “About Deep learning algorithm for BET” below. This brain extraction algorithm uses a 3D U-Net architecture, consisting of 6 layers (16, 32, 64, 128, 256, 512), and was optimized using both DICE and Tversky metrics.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (4)

Retrospective clinical

n=100 cases

endpoints: assess performance stability and generalizability across different scanner types and patient profiles; demonstrate excellent spatial overlap between automated segmentations and expert-annotated ground truth masks; high segmentation accuracy and consistent reliability across diverse clinical scenarios

Bench

sample size not stated

endpoints: Product risk assessment; Software modules verification tests; Usability assessment; Software validation test

Reader study (MRMC)

n=30 cases

endpoints: substantial equivalence of performance between Neuro Insight V1.0 subject device and Olea Sphere® V3.0 predicate device

Reader study (MRMC)

n=60 cases

endpoints: acceptable for reading and interpretation

Reported performance (1 observation)

diceas written: “DICE coefficient”0.97CI 0.907 to 0.988

source quote (p.9)

“The achieved average DICE coefficient of 0.97, ranging from 0.907 to 0.988, exceeds the predetermined acceptance threshold of 0.95.”

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

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).