NeuroQuant

K170981

CorTechs Labs, Inc · cleared 2017-09-07 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“NeuroQuant is a fully automated MR imaging post-processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and lesions from a set of MR images and returns segmented images and morphometric reports.”

Algorithmproprietary automated internal pipeline that performs artifact correction, atlas-based segmentation, volume calculation and report generation; uses a dynamic probabilistic neuroanatomical atlas, with age and gender specificity, based on the MR image intensity

source quote (p.5)

“The NeuroQuant processing architecture includes a proprietary automated internal pipeline that performs artifact correction, atlas-based segmentation, volume calculation and report generation. Automatic segmentation and quantification of brain structures using a dynamic probabilistic neuroanatomical atlas, with age and gender specificity, based on the MR image intensity”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.5)

“Additionally, automated safety measures include automated quality control functions, such as tissue contrast check, atlas alignment check and scan protocol verification, which validate that the imaging protocols adhere to system requirements.”

Validation studies (1)

Standalone

sample size not stated

endpoints: segmentation accuracy using Dice's coefficient metric; brain structure segmentation reproducibility using percentage absolute volume differences; lesion segmentation reproducibility using mean absolute lesion volume difference and mean percentage lesion absolute volume difference

Reported performance (3 observations)

diceas written: “Dice's coefficient for major subcortical brain structures”stated without valueCI 80-90%

source quote (p.7)

“For major subcortical brain structures Dice's coefficients are in the range of 80-90%”

diceas written: “Dice's coefficient for major cortical regions”stated without valueCI 75-85%

source quote (p.7)

“and for major cortical regions are in the range of 75-85%.”

diceas written: “Dice's coefficient for lesion segmentations”stated without valueCI >80%

source quote (p.7)

“For lesion segmentations evaluated separately using 3D T1 and T2 FLAIR MRI scan pairs of subjects with brain lesions, Dice's coefficient exceeds 80%.”

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) K241098 (decision 2024-08-22) from CorTechs Labs, Inc. for a matching device line ("NeuroQuant") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241098
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
…and 21 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).