MR Diffusion Perfusion Mismatch V1.0
K-Number: K223502 · 2023-01-13
ApplicantOlea Medical
Decision Date2023-01-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MR Diffusion Perfusion Mismatch V1.0 is a medical device manufactured by Olea Medical. It received FDA 510(k) clearance on 2023-01-13 under approval number K223502. 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 Diffusion Perfusion Mismatch V1.0?
MR Diffusion Perfusion Mismatch V1.0 is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Olea Medical. The 510(k) number is K223502.
When was MR Diffusion Perfusion Mismatch V1.0 approved by the FDA?
MR Diffusion Perfusion Mismatch V1.0 received FDA 510(k) clearance on 2023-01-13, under approval number K223502.
What company makes MR Diffusion Perfusion Mismatch V1.0?
MR Diffusion Perfusion Mismatch V1.0 is manufactured by Olea Medical.
What is the FDA product code for MR Diffusion Perfusion Mismatch V1.0?
The FDA product code for MR Diffusion Perfusion Mismatch V1.0 is LLZ.
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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.