Sora Neuroscience, Inc. - FDA 510(k) Cleared Devices

Sora Neuroscience, Inc. develops resting-state fMRI software for brain mapping and surgical planning. The company is based in Minneapolis, Minnesota, with a team of neuroradiologists, neurosurgeons, data scientists, and software developers. Their technology builds on a decade of clinical research from Washington University in St. Louis.

Sora Neuroscience has received 1 FDA 510(k) clearance from 1 total submission in the Radiology category. The company achieved its first and latest clearance in 2025, demonstrating active regulatory engagement. The cleared device, Cirrus Resting State fMRI Software, enables automated brain mapping for surgical planning without requiring patient task performance.

Cirrus is designed for plug-and-play integration into existing imaging and neurosurgery platforms. The software expands access to fMRI mapping for patients unable to perform task-based scans, including children and cognitively impaired patients. Output maps integrate seamlessly with hospital surgical navigation systems for clinical decision-making.

Explore the company's cleared device names, product codes, and clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.