Olea Sphere V3.0

FDA 510(k) K152602 · Olea Medical

Substantially Equivalent

510(k) numberK152602

Submission

Device name
Olea Sphere V3.0
Applicant
Olea Medical
La Ciotat, FR
Received
September 11, 2015
Decision date
March 3, 2016
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 Olea Sphere V3.0 cleared by the FDA?

Olea Sphere V3.0 (K152602) received a 510(k) decision of Substantially Equivalent on March 3, 2016, 174 days after the submission was received.

What is the product code of K152602?

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