Cirrus Resting State fMRI Software— 510(k) K251009

Substantially Equivalent

Sora Neuroscience, Inc.

FDA 510(k) clearance K251009 for Cirrus Resting State fMRI Software, Substantially Equivalent on 2025-06-06. Applicant: Sora Neuroscience, Inc.. Device class: 2.

Clearance details

Applicant
Sora Neuroscience, Inc.
Product code
Code QIH
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
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