BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    APPLIED SPECTRAL IMAGING, LTD.

    Reg #: 9615060 · FEI: 3009505338 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    APPLIED SPECTRAL IMAGING, LTD.
    Registration Number
    9615060
    FEI Number
    3009505338
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 HaCarmel St., New Industrial Zone
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K012103

    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
    Yaniv Giron

    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
    Analyzer, Chromosome, Automated LNJ
    System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays NTH
    Device, Automated Cell-Locating JOY
    Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity NQN
    Microscope, Automated, Image Analysis, Operator Intervention NOT
    Light, Microscope IBJ

    Proprietary Names

    CytoPower BandView HiBand BandView GenASIs BandView SpotScan UroVysion GenASIs Scan & Analysis UroVision PathFusion SpotScan UroVision HiFISH SpotScan UroVision CytoPower SpotScan UroVision SpotScan ALK CytoPower SpotScan ALK GenASIs Scan & Analysis ALK HiFISH SpotScan ALK ScanView ALK PathFusion SpotScan ALK SpotScan CEP XY CytoPower SpotScan CEP XY GenASIs Scan & Analysis CEP XY HiFISH SpotScan CEP XY HiFISH FISHView PathFusion FISHView CytoPower FISHView GenASIs FISHView HiFISH SpotScan HER2/neu PathFusion SpotScan HER2/neu CytoPower SpotScan HER2/neu GenASIs Scan & Analysis HER2/neu ScanView HER2/neu SpotScan HER2/neu HiPath Pro IHC Family GenASIs HiPath IHC Family PathFusion HiPath IHC Family HiBand Metscan GenASIs MetScan CytoPower MetScan ScanView MetScan

    Establishment Types

    Manufacture Medical Device