K251009
- 510(k) number
- K251009
- Device name
- Cirrus Resting State fMRI Software
- Applicant
- Sora Neuroscience, Inc. MN · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-06-06
- Date received
- 2025-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251009.pdf
Official FDA record: K251009
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.