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FDA 510(k)

CT Perfusion V1.0

K-Number: K223091 · 2023-06-09

ApplicantOlea Medical
Decision Date2023-06-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT Perfusion V1.0 is a medical device manufactured by Olea Medical. It received FDA 510(k) clearance on 2023-06-09 under approval number K223091. 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 CT Perfusion V1.0?

CT Perfusion V1.0 is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Olea Medical. The 510(k) number is K223091.

When was CT Perfusion V1.0 approved by the FDA?

CT Perfusion V1.0 received FDA 510(k) clearance on 2023-06-09, under approval number K223091.

What company makes CT Perfusion V1.0?

CT Perfusion V1.0 is manufactured by Olea Medical.

What is the FDA product code for CT Perfusion V1.0?

The FDA product code for CT Perfusion V1.0 is LLZ.

Other Devices by Olea Medical

K152602Olea Sphere V3.0 K211431breastscape v1.0 K223532Olea S.I.A. Neurovascular V1.0 K230552MR DWI/FLAIR Measurement V1.0 K223502MR Diffusion Perfusion Mismatch V1.0

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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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