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FDA 510(k)

Cirrus Resting State fMRI Software

K-Number: K251009 · 2025-06-06

ApplicantSora Neuroscience, Inc.
Decision Date2025-06-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cirrus Resting State fMRI Software is a medical device manufactured by Sora Neuroscience, Inc.. It received FDA 510(k) clearance on 2025-06-06 under approval number K251009. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cirrus Resting State fMRI Software?

Cirrus Resting State fMRI Software is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Sora Neuroscience, Inc.. The 510(k) number is K251009.

When was Cirrus Resting State fMRI Software approved by the FDA?

Cirrus Resting State fMRI Software received FDA 510(k) clearance on 2025-06-06, under approval number K251009.

What company makes Cirrus Resting State fMRI Software?

Cirrus Resting State fMRI Software is manufactured by Sora Neuroscience, Inc..

What is the FDA product code for Cirrus Resting State fMRI Software?

The FDA product code for Cirrus Resting State fMRI Software is QIH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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