AP-NV-FR-CT;AP-NV-FR-MR

Organization name

Olea Medical S.A.S.

SRN

FR-MF-000002403

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 17 countries total.

Trade name

not provided

UDI-DI code

+EOLENEUROVASV1P00

Basic UDI-DI

++EOLENEUROVAS8M

Reference / catalog number

AP-NV-FR-CT;AP-NV-FR-MR

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

OLEA S.I.A. Neurovascular V1.0 supports the visualization of DICOM series and edition of some modifiable parameters. OLEA S.I.A. Neurovascular V1.0 is a web interface embedded on the Automation Platform V1.5, formerly Olea S.I. A V1.0 platform, that uses its components to read the outputs of docker applications. To access OLEA S.I.A. Neurovascular V1.0, the results of at least one compatible application must be available within the Automation Platform V1.5, to provide input to the user interface. After edition, the modified parameters are provided through the Automation Platform V1.5 as inputs to the docker applications to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs. Olea S.I.A. Neurovascular V1.0 is only compatible for PC workstations and is not designed to be used with any mobile devices.

Additional information URL

https://www.olea-medical.com/en/customer/connexion/

Clinical sizes

No clinical sizes registered for this device.

• Z11050182MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES

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• Software identification