K261273

Neurophet AQUA

510(k) number
K261273
Device name
Neurophet AQUA
Applicant
Neurophet., Inc. KR
Product code
QIH — Automated Radiological Image Processing Software
Decision date
2026-05-15
Date received
2026-04-17
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K261273.pdf
Official FDA record: K261273
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.