Data / Medical devices / United States / Sora Neuroscience
Sora Neuroscience: FDA-registered device maker in Minneapolis, MN, United States, 1 510(k) clearance
Sora Neuroscience is registered with the FDA (registration 3047514296) in Minneapolis, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3047514296
- Address
- 4406 Beard Ave S Ste UL2, Minneapolis, MN, United States, 55410
- Owner or operator
- Sora Neuroscience (10096226)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 30, 2026
- Registered through
- 2026
- Brand names listed
- Cirrus Resting-State fMRI Software - Version 1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | K251009 | Cirrus Resting State fMRI Software | QIH | Substantially Equivalent | Sora Neuroscience, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.