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    FDA UDI In Commercial Distribution 🇺🇸 United States

    XperCT Dual

    DI: 00884838059306 · Model: XperCT Dual - 3 · 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
    XperCT Dual
    Primary DI
    00884838059306
    Version / Model
    XperCT Dual - 3
    Catalog Number
    001105
    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
    2016-09-24
    Public Version
    8
    Public Version Date
    2023-09-26
    Public Version Status
    Update
    Public Device Record Key
    ccced8fd-0485-4734-8d55-37df01a9bce2

    Device Description

    Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician.

    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
    OWB Interventional Fluoroscopic X-Ray System
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    40868 Angiographic x-ray system application software

    Identifiers

    Type ID
    Primary 00884838059306

    Premarket Submissions

    Submission Number Supplement Number
    K130893 000