MOD001;MOD002;MOD003;MOD004;MOD005;MOD007;MOD008;MOD010;MOD011;MOD012;MOD013;MOD014;MOD015;MOD016;MOD017;MOD020;MOD021

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 23 countries total.

Trade name

not provided

UDI-DI code

+EOLEOLEASPHEREV3P00

Basic UDI-DI

++EOLEOLEASPHEREA3

Reference / catalog number

MOD001;MOD002;MOD003;MOD004;MOD005;MOD007;MOD008;MOD010;MOD011;MOD012;MOD013;MOD014;MOD015;MOD016;MOD017;MOD020;MOD021

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 Sphere® V3.0 is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard. Olea Sphere® V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. Depending on the studies content, these features may be provided by the following optional plug-in: • Diffusion (MR imaging) • Multi-b (MR imaging) • DTI (MR imaging) • Perfusion (MR and CT imaging) • Permeability (MR and CT imaging) • Kinetics (MR imaging) • ASL (MR imaging) • Analysis (MR and CT imaging) • Olea Vision (MR and CT imaging) • Collage (MR imaging) • Metabolic (MR imaging) • Relaxometry (MR imaging) The main users of the program are medical imaging professionals who need to visualize and analyze images acquired primarily with MRI or CT systems.

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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