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FDA 510(k)

OptimMRI (v2)

K-Number: K242054 · 2024-08-12

ApplicantRebrain, Sas
Decision Date2024-08-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OptimMRI (v2) is a medical device manufactured by Rebrain, Sas. It received FDA 510(k) clearance on 2024-08-12 under approval 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. It is manufactured by Rebrain, Sas. The 510(k) number is K242054.

When was OptimMRI (v2) approved by the FDA?

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

What company makes OptimMRI (v2)?

OptimMRI (v2) is manufactured by Rebrain, Sas.

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

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

Other Devices by Rebrain, Sas

K230150OptimMRI

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Official Source

View on FDA Database →

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