Neurophet AQUA AD Plus

Evidence summary

FDA summary describes module-specific independent validation datasets held separate from training data: 60 T1 MRI cases, 136 FLAIR cases, 30 paired MRI-PET datasets, 176 paired T1/PET scans for Centiloid classification, 100 edema-like FLAIR scans and 106 GRE/SWI scans. These are different tests, not one pooled clinical cohort.

FDA source Exact FDA submission Checked 2026-09-06

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-06

Downloaded exact-ID recall packet contained zero records; that limited result does not establish absence of recall or safety information.

• Verify deployment and data flow: The reviewed FDA summary describes DICOM input/output but does not establish the complete commercial hosting, on-premise/cloud topology or upgrade workflow.
• Verify security and privacy controls: No scoped dated security certification, data-flow description, retention policy or exact-release access-control evidence was established.
• Verify training: Current workflow training, reader qualification and support arrangements require vendor confirmation.
• Verify pricing and total cost: No public U.S. list price, installation charge or license term was identified in reviewed primary sources.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed; FDA clearance and vendor announcement do not establish coverage or separate payment.
• Verify local validation and lifecycle monitoring: Public sources reviewed do not establish site-level production monitoring, update acceptance or incident escalation.
• Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; that limited result does not establish absence of recall or safety information.

Stored literature-index and trial-registry candidate arrays were empty and screened. This does not assert that no literature or trials exist; no unscreened study is promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, acr ai central product, fda decision summary, vendor announcement, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

• Neurophet AQUA AD Plus: K252496 clearance and 510(k) summary U.S. Food and Drug Administration · 2026-09-06
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Neurophet AQUA AD Plus model card (K252496) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Neurophet AQUA AD Plus FDA-clearance announcement Neurophet · 2026-09-06