BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ingenia

    DI: 00884838125698 · Model: BlueSeal SE · Philips Medical Systems Nederland B.V.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ingenia
    Primary DI
    00884838125698
    Version / Model
    BlueSeal SE
    Catalog Number
    782185
    Company Name
    Philips Medical Systems Nederland B.V.
    Labeler DUNS
    413819707
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-06
    Public Version
    2
    Public Version Date
    2025-12-15
    Public Version Status
    Update
    Public Device Record Key
    84ccd762-d646-46a3-a4dd-e26783fab770

    Device Description

    Excel in your daily MR services Based on its revolutionary fully sealed BlueSeal magnet, BlueSeal SE lets you experience more productive¹ helium-free MR operations. The BlueSeal SE delivers superb image quality with up to 80% sharper images2 even for challenging patients, and performs MRI exams up to 3x faster3 with SmartSpeed Precise accelerations for all anatomies. Fast overall exam-time is achieved by simplifying patient handling at the bore with the guided patient setup. Furthermore, the BlueSeal SE offers an immersive audio-visual experience to help calm patients and guide them through MR exams. 1 Compared to the Ingenia 1.5T ZBO magnet. 2 Compared to Philips SENSE/ C-SENSE imaging. 3 Compared to Philips SENSE imaging.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LNH System, Nuclear Magnetic Resonance Imaging
    LNI System, Nuclear Magnetic Resonance Spectroscopic

    GMDN Terms

    Code Name
    37654 Full-body MRI system, superconducting magnet

    Identifiers

    Type ID
    Primary 00884838125698