Cleared Traditional

K132095 - OLEA SPHERE

K132095 is an FDA 510(k) clearance for OLEA SPHERE, manufactured by Olea Medical. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K132095 · Olea Medical · Radiology device
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Dec 2013
Decision
171d
Days
Class 2
Risk

K132095 is an FDA 510(k) clearance for the OLEA SPHERE. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Olea Medical (La Ciotat, FR). The FDA issued a Cleared decision on December 26, 2013 after a review of 171 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

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FDA 510(k) Submission Details - K132095

510(k) Number K132095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2013
Decision Date December 26, 2013
Days to Decision 171 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 107d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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