GyriCalc (Version 1.0.0)

510(k)K250686RadiologyLLZ

NeuroSpectrum Insights Corp. is listed for GyriCalc (Version 1.0.0) (K250686). The FDA list gives July 22, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LLZ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250686

Official FDA database record

Date of final decision: July 22, 2025
Company on the FDA list: NeuroSpectrum Insights Corp.
Lead panel: Radiology
Primary product code: LLZ
openFDA device name for the code: System, Image Processing, Radiological
Device class: 2
Regulation number: 892.2050
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary