Neurophet AQUA

K220437

NEUROPHET, Inc. · cleared 2023-05-10 · product code LLZ · Radiology

FDA 510(k) summary for Neurophet AQUA (K220437)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
2
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.”
Algorithmdeep learning
source quote (p.6)
“Automatic segmentation and quantification of brain structures using deep learning”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=64 scans · 3 site(s)

endpoints: segmentation accuracy; segmentation reproducibility

Reported performance (2 observations)

diceas written: “Dice's coefficient for major subcortical brain structures”stated without valueCI 80-90%
source quote (p.9)
“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.9)
“and for major cortical regions are in the range of 75-85%.”

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
37
drift signals on this device
  • predicate_cohort_contagion

    K220437 shares predicate K170981 with K221738 (NS-HGlio), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K170981 sibling:K221738

  • predicate_cohort_contagion

    K220437 shares predicate K170981 with K232231 (QP-Brain®), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K170981 sibling:K232231

  • predicate_cohort_contagion

    K220437 shares predicate K170981 with K241098 (NeuroQuant), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K170981 sibling:K241098

  • predicate_cohort_contagion

    K220437 shares predicate K170981 with K242215 (Neurophet AQUA (V3.1)), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K170981 sibling:K242215

  • predicate_cohort_contagion

    K220437 shares predicate K202414 with K220815 (BrainInsight), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K202414 sibling:K220815

  • 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

  • …and 31 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-09-02.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K220437