BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    PathFusion SpotScan HER2/neu

    Reg #: 9615060 · FEI: 3009505338 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    APPLIED SPECTRAL IMAGING, LTD.
    Registration Number
    9615060
    FEI Number
    3009505338
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 HaCarmel St., New Industrial Zone
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K101291

    Owner / Operator

    Firm Name
    APPLIED SPECTRAL IMAGING Ltd.
    Operator Number
    9031915
    Address
    2 HaCarmel St., New Industrial Zone
    City
    Yokneam
    State
    Northern
    Postal Code
    2069204
    Country
    IL
    Correspondent
    Limor Shiposh

    US Agent

    Business Name
    APPLIED SPECTRAL IMAGING INC.
    Contact Name
    Reut Sagiv
    Address
    6160 Innovation Way
    City
    Carlsbad
    State
    CA
    ZIP
    92009
    Country
    US
    Email
    [email protected]
    Phone
    800 6113466 ext. 0

    Products

    Device Name Product Code
    System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays NTH

    Proprietary Names

    PathFusion SpotScan HER2/neu ScanView HER2/neu HiFISH SpotScan HER2/neu SpotScan HER2/neu CytoPower SpotScan HER2/neu GenASIs Scan & Analysis HER2/neu

    Establishment Types

    Manufacture Medical Device