Data / Medical devices / France / Olea Medical

Olea Medical: FDA-registered device maker in La Ciotat Bouches-du-Rhone, France, 8 510(k) clearances

Name: Olea Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Olea Medical is registered with the FDA (registration 3007675959) in La Ciotat Bouches-du-Rhone, France. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 25, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007675959
Address: 93 Avenue du Sorbier, Zone Athelia IV, La Ciotat Bouches-du-Rhone, France, 13600
Owner or operator: Olea Medical S.A.S. (10028761)
Roles: Manufacturer
First device listed: September 20, 2016
Registered through: 2026
Brand names listed: Automation Platform V1.5, Automation Platform V3, Automation Platform V3.1, CT Perfusion V1, Functional MR V1, MR DWI/FLAIR Measurement V1, MR Diffusion Perfusion Mismatch V1, Neuro Insight V1 and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 25, 2025	K243680	Neurovascular Insight V1.0	LLZ	Substantially Equivalent	Olea Medical S.A.S.	accessdata.fda.gov
July 23, 2025	K243681	Neuro Insight V1.0	LLZ	Substantially Equivalent	Olea Medical S.A.S.	accessdata.fda.gov
June 9, 2023	K223091	CT Perfusion V1.0	LLZ	Substantially Equivalent	Olea Medical	accessdata.fda.gov
April 26, 2023	K230552	MR DWI/FLAIR Measurement V1.0	LLZ	Substantially Equivalent	Olea Medical	accessdata.fda.gov
January 13, 2023	K223502	MR Diffusion Perfusion Mismatch V1.0	LLZ	Substantially Equivalent	Olea Medical	accessdata.fda.gov
July 6, 2022	K221426	Functional MR V1.0	LLZ	Substantially Equivalent	Olea Medical S.A.S.	accessdata.fda.gov
August 2, 2021	K211431	breastscape v1.0	QIH	Substantially Equivalent	Olea Medical	accessdata.fda.gov
March 3, 2016	K152602	Olea Sphere V3.0	LLZ	Substantially Equivalent	Olea Medical	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 10, 2023	93049	Class II	Ongoing	Functional MR V1.0	When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.	accessdata.fda.gov

Compare with other makers

Updated August 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.