FDA.reportPublic FDA data

OLEA MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076759593007675959OLEA MEDICAL1N2026-01-0193 Avenue du Sorbier, Zone Athelia IV La Ciotat Bouches-du-Rhone FR 13600

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1007861023919997K243681Neuro Insight V1.0LLZ2025-07-23
1007861943675985K243680Neurovascular Insight V1.0LLZ2025-08-25
1007861904932435K230552MR DWI/FLAIR Measurement V1.0LLZ2023-04-26
1007862045997097K223502MR Diffusion Perfusion Mismatch V1.0LLZ2023-01-13
1007861361442600K223091CT Perfusion V1.0LLZ2023-06-09
1007861086324858K221426Functional MR V1.0LLZ2022-07-06
1007861581607463K211431breastscape v1.0QIH2021-08-02
1007861259021974K152602Olea Sphere V3.0LLZ2016-03-03
1007861970785050

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ72025-08-25
QIH12021-08-02

PMN#