Singapore HSA registration DE0505227
Olea Medical Olea Sphere
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0505227
- Registration Date
- December 09, 2020
- Retention Due Date
- December 08, 2025
Product description
Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT).”
Product Owner
- Short Name
- OLEA MEDICAL S.A.S.
- Address
- ZI Athelia IV, 93 Avenue des Sorbiers, 13600 LA CIOTAT, FRANCE
Registrant
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
- Address
- 211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model information
- Model Name(s)
- OLEA SPHERE
- Model Identifier(s)
- OLEA SPHERE
About this record
Access comprehensive regulatory information for Olea Medical Olea Sphere in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505227 and owned by OLEA MEDICAL S.A.S.. The device was registered on December 09, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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