CT Perfusion V1.0

FDA 510(k) K223091 · Olea Medical

Substantially Equivalent

510(k) numberK223091

Submission

Device name
CT Perfusion V1.0
Applicant
Olea Medical
La Ciotat, FR
Received
September 30, 2022
Decision date
June 9, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

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

CT Perfusion V1.0 (K223091) received a 510(k) decision of Substantially Equivalent on June 9, 2023, 252 days after the submission was received.

What is the product code of K223091?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.