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FDA 510(k)

MR DWI/FLAIR Measurement V1.0

K-Number: K230552 · 2023-04-26

ApplicantOlea Medical
Decision Date2023-04-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MR DWI/FLAIR Measurement V1.0 is a medical device manufactured by Olea Medical. It received FDA 510(k) clearance on 2023-04-26 under approval number K230552. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR DWI/FLAIR Measurement V1.0?

MR DWI/FLAIR Measurement V1.0 is a medical device that received FDA 510(k) clearance on 2023-04-26. It is manufactured by Olea Medical. The 510(k) number is K230552.

When was MR DWI/FLAIR Measurement V1.0 approved by the FDA?

MR DWI/FLAIR Measurement V1.0 received FDA 510(k) clearance on 2023-04-26, under approval number K230552.

What company makes MR DWI/FLAIR Measurement V1.0?

MR DWI/FLAIR Measurement V1.0 is manufactured by Olea Medical.

What is the FDA product code for MR DWI/FLAIR Measurement V1.0?

The FDA product code for MR DWI/FLAIR Measurement V1.0 is LLZ.

Other Devices by Olea Medical

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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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