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FDA 510(k)

OptimMRI

K-Number: K230150 · 2023-07-21

ApplicantRebrain, Sas
Decision Date2023-07-21
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OptimMRI is a medical device manufactured by Rebrain, Sas. It received FDA 510(k) clearance on 2023-07-21 under approval number K230150. 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?

OptimMRI is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Rebrain, Sas. The 510(k) number is K230150.

When was OptimMRI approved by the FDA?

OptimMRI received FDA 510(k) clearance on 2023-07-21, under approval number K230150.

What company makes OptimMRI?

OptimMRI is manufactured by Rebrain, Sas.

What is the FDA product code for OptimMRI?

The FDA product code for OptimMRI is QIH.

Other Devices by Rebrain, Sas

K242054OptimMRI (v2)

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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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