Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007675959

FEI Number

3007675959

Entity Name

OLEA MEDICAL

City/State/Country

La Ciotat Bouches-du-Rhone, FR

Establishment Address

93 Avenue du Sorbier, Zone Athelia IV, La Ciotat Bouches-du-Rhone 13600, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Olea Medical S.A.S. (Owner Number: 10028761)

Owner / Operator Contact Address

93 Avenue du Sorbier, Zone Athelia IV, La Ciotat, FR-13 13600, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211431

PMA Number

N/A

All Registered Proprietary Names

MR Diffusion Perfusion Mismatch V1 Neurovascular Insight V1 MR DWI/FLAIR Measurement V1 Neuro Insight V1 Automation Platform V3 Olea S.I.A V1 Automation Platform V1.5 Automation Platform V3.1 OLEA SPHERE V3 CT Perfusion V1 breastscape V1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-02-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-05-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-02-06
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2019-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-09-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-06-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-09-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-09-03

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Olea Medical S.A.S.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3017991646	CARDIOWISE, INC.	Fayetteville, AR, US
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007675959. Last updated year: 2026. Please use registration number 3007675959 when referencing this establishment in official correspondence.