K250686
- 510(k) number
- K250686
- Device name
- GyriCalc (Version 1.0.0)
- Applicant
- Neurospectrum Insights Corp. NJ · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-07-22
- Date received
- 2025-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250686.pdf
Official FDA record: K250686
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.