Neurophet AQUA

K220437

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

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
28
drift signals on this device
  • 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242215 (decision 2024-10-25) from Neurophet, Inc. for a matching device line ("Neurophet AQUA (V3.1)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242215

  • 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

  • …and 22 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 2026-07-08.

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).

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.

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