510(k) Report

FDA applicant

Olea Medical

La Ciotat, FR14 decisions2009–20251 recall

FDA records 14 decisions for Olea Medical (La Ciotat, FR) from 2009 to 2025: 14 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Olea Medical S.A.S.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Olea Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2009: 22011: 12012: 12013: 12016: 12021: 12022: 12023: 42025: 2
2009high 4 (2023) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2009high 1 (2023) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Olea Medical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological12decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 174 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 157 days; 4 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152602Olea Sphere V3.0Olea Medical · 201611cite it
  • K120196Olea SphereOlea Medical · 20123cite it
  • K132095Olea SphereOlea Medical · 20133cite it
  • K111161Perfscape V2.0Olea Medical · 20112cite it
  • K223532Olea S.I.A. Neurovascular V1.0Olea Medical · 20231cites it

What has FDA decided for it lately?

  • K243680Neurovascular Insight V1.0Olea Medical S.A.S. · 2025
  • K243681Neuro Insight V1.0Olea Medical S.A.S. · 2025
  • K223091CT Perfusion V1.0Olea Medical · 2023
  • K223532Olea S.I.A. Neurovascular V1.0Olea Medical · 2023
  • K230552MR DWI/FLAIR Measurement V1.0Olea Medical · 2023
  • K223502MR Diffusion Perfusion Mismatch V1.0Olea Medical · 2023
  • K221426Functional MR V1.0Olea Medical S.A.S. · 20221 recall
  • K211431breastscape v1.0Olea Medical · 2021

All 11 as Olea Medical →All 3 as Olea Medical S.A.S. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K221426Functional MR V1.0Aug 10, 2023Class II