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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 the device name listed in this FDA 510(k) record. The listed applicant is Sora Neuroscience, Inc.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) 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. The listed applicant is Sora Neuroscience, Inc.. The 510(k) number is K251009.

When did Cirrus Resting State fMRI Software receive FDA 510(k) clearance?

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

Who is the listed applicant for Cirrus Resting State fMRI Software?

The FDA 510(k) record lists Sora Neuroscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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