Neurophet AQUA (V3.1)
K242215Neurophet, Inc. · cleared 2024-10-25 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Neurophet AQUA is a fully automated MR imaging post-processing medical device software that provides automatic labeling, visualization, and volumetric quantification of brain structures from a set of MR images and returns segmented images and morphometric reports.”
source quote (p.9)
“About the deep learning algorithm, the analysis performance is tested and validated as below:”
Validation studies (1)
Retrospective clinical
n=136 images
endpoints: segmentation accuracy; segmentation reproducibility
Reported performance (1 observation)
source quote (p.9)
“Neurophet AQUA's lesion segmentation accuracy compared to expert manual segmentations of T2 FLAIR scan was evaluated using Dice's coefficient metric, which exceeds 0.80.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252496 (decision 2026-01-29) from Neurophet., Inc. for a matching device line ("Neurophet AQUA AD Plus") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252496
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).