Functional MR V1.0

FDA 510(k) K221426 · Olea Medical S.A.S.

Substantially Equivalent

510(k) numberK221426

Submission

Device name
Functional MR V1.0
Applicant
Olea Medical S.A.S.
La Ciotat, FR
Received
May 16, 2022
Decision date
July 6, 2022
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 Functional MR V1.0 cleared by the FDA?

Functional MR V1.0 (K221426) received a 510(k) decision of Substantially Equivalent on July 6, 2022, 51 days after the submission was received.

What is the product code of K221426?

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