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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 the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2023-04-26 under 510(k) 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. The listed applicant is Olea Medical. The 510(k) number is K230552.

When did MR DWI/FLAIR Measurement V1.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for MR DWI/FLAIR Measurement V1.0?

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

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 records listing Olea Medical 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.

K223091CT Perfusion V1.0K223532Olea S.I.A. Neurovascular V1.0K223502MR Diffusion Perfusion Mismatch V1.0K211431breastscape v1.0K152602Olea Sphere V3.0

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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