BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR DWI/FLAIR Measurement

    DI: EOLEMRDFMV1P00 · Model: V1.0 · Olea Medical USA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MR DWI/FLAIR Measurement
    Primary DI
    EOLEMRDFMV1P00
    Version / Model
    V1.0
    Company Name
    Olea Medical USA
    Labeler DUNS
    047358761
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-04
    Public Version
    2
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    7b5f2646-9910-4713-8278-e49bfd55a03e

    Device Description

    MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of: (1) MR Diffusion-weighted imaging (DWI) (2) MR FLAIR images. The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow: • computation of the map relative to the water diffusion, i.e., ADC map; • extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images. The results of MR DWI/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary EOLEMRDFMV1P00

    Customer Contacts

    Phone
    +33442712420
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K230552 000