K251009

Substantially Equivalent

Cirrus Resting State fMRI Software

Applicant: Sora Neuroscience, Inc.
Product code: QIH
Advisory panel: Radiology
Date received: 2025-04-01
Decision date: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.