Clearance Summary
Cirrus Resting State fMRI Software received FDA 510(k) clearance under submission number K251009, sponsored by Sora Neuroscience, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-06-06.
- Submission: K251009
- Applicant / Sponsor: Sora Neuroscience, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2025-06-06
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.