BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BrainSpec Core™ Software

    DI: 00860013965204 · Model: BrainSpec Core™ Software · BrainSpec Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BrainSpec Core™ Software
    Primary DI
    00860013965204
    Version / Model
    BrainSpec Core™ Software
    Company Name
    BrainSpec Inc.
    Labeler DUNS
    080177248
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-01
    Public Version
    1
    Public Version Date
    2025-05-09
    Public Version Status
    New
    Public Device Record Key
    e13017d6-e664-477a-b56b-9ea2ad212eb7

    Device Description

    BrainSpec Core™ Software is a web-based software platform that allows for the interpretation of magnetic spectroscopy data to display relative levels of brain metabolites.

    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
    LNI System, Nuclear Magnetic Resonance Spectroscopic

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 00860013965204

    Premarket Submissions

    Submission Number Supplement Number
    K230856 000