Olea Medical S.A.S.
France FR-MF-000002403 Last updated 17 Sep 2026
- Devices
- 10
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
MR Diffusion Perfusion Mismatch V1.0 Ref AP-NV-DP-MR
Olea S.I.A. Neurovascular V1.0 Ref AP-NV-FR-CT;AP-NV-FR-MR
Functional MR V1.0 Ref MOD030
AI DWI Mismatch V1.0 Ref AP-NV-AIDM-MR
Neuro Insight V1.0 Ref AP-NI-MR; AP-NI-NP-MR; AP-NI-NS-MR
breastscape V1.0 Ref SCPT001;SCPT002
MR DWI/FLAIR Measurement V1.0 Ref AP-NV-DF-MR
Olea Sphere V3.0 Ref MOD001;MOD002;MOD003;MOD004;MOD005;MOD007;MOD008;MOD010;MOD011;MOD012;MOD013;MOD014;MOD015;MOD016;MOD017;MOD020;MOD021
CT Perfusion V1.0 Ref AP-NV-CTP
Neurovascular Insight V1.0 Ref AP-NVI-CT; AP-NVI-MR
What Olea Medical S.A.S. makes
Olea Medical S.A.S. develops software-based medical imaging solutions for diagnostic analysis, including tools for neurovascular imaging, diffusion-weighted imaging (DWI), and perfusion studies. Their portfolio includes applications for functional MRI (fMRI), AI-assisted DWI mismatch detection, and breast imaging analysis, as well as tools for measuring MRI and CT perfusion metrics. Additional offerings focus on neurovascular and brain imaging insights, such as vascular structure analysis and automated segmentation.
The company’s devices are classified under EU Class IIa and are registered in the EU’s eudamed database. Their products are designed for integration with MRI and CT systems, adhering to regulatory requirements for software-as-a-medical-device (SaMD) under EU MDR. The manufacturer is based in France.
Information
- Country
- France
- Address
- 93, ZI ATHELIA IV - Avenue des Sorbiers, La Ciotat, France
- Website
- olea-medical.com
- [email protected]
- PRRC contact
- Nathalie Palumbo
- EUDAMED SRN
- FR-MF-000002403