FDA 510(k)

OptimMRI (v2)

K-Number: K242054 · 2024-08-12

Decision Date2024-08-12

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OptimMRI (v2) is the device name listed in this FDA 510(k) record. The listed applicant is Rebrain, Sas. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K242054. 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 OptimMRI (v2)?

OptimMRI (v2) is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Rebrain, Sas. The 510(k) number is K242054.

When did OptimMRI (v2) receive FDA 510(k) clearance?

OptimMRI (v2) received FDA 510(k) clearance on 2024-08-12, under 510(k) number K242054.

Who is the listed applicant for OptimMRI (v2)?

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

What is the FDA product code for OptimMRI (v2)?

The FDA product code for OptimMRI (v2) is QIH.

Other records listing Rebrain, Sas as applicant

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.

K230150OptimMRI

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Official Source

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