NeuroQuant
K241098CorTechs Labs, Inc. · cleared 2024-08-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“NeuroQuant is a fully automated MR imaging post-processing software medical device 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.”
source quote (p.6)
“Automatic segmentation and quantification of brain structures and lesions using a dynamic probabilistic neuroanatomical atlas, with age and gender specificity, based on the MR image intensity and static deep-learning technologies”
source quote (p.7)
“Addition of static deep-learning technologies”
Validation studies (3)
Retrospective clinical
n=30 patients · 16 site(s)
endpoints: Dice Similarity Coefficient (DSC)
Retrospective clinical
n=63 patients · 22 site(s)
endpoints: Dice Similarity Coefficient (DSC)
Retrospective clinical
n=117 patients · 68 site(s)
endpoints: F1 Score
Reported performance (2 observations)
source quote (p.8)
“achieving a mean Dice Similarity Coefficient (DSC) of 0.70 with a standard deviation of 0.14”
source quote (p.8)
“achieving a median F1 Score of 0.60”
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
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).