BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    NanoZoomer S360MD Slide scanner system

    Reg #: 9614683 · FEI: 3003794634 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION
    Registration Number
    9614683
    FEI Number
    3003794634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    812 JOKO-CHO, CHUO-KU
    City
    HAMAMATSU CITY Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K213883

    Owner / Operator

    Firm Name
    HAMAMATSU PHOTONICS, K.K.
    Operator Number
    8031665
    Address
    325-6 SUNAYAMA-CHO, CHUO-KU, --
    City
    HAMAMATSU CITY
    State
    Shizuoka
    Postal Code
    430-8587
    Country
    JP

    US Agent

    Business Name
    HAMAMATSU CORP.
    Contact Name
    Teresa Carroll
    Address
    360 FOOTHILL RD.
    City
    BRIDGEWATER
    State
    NJ
    ZIP
    08807
    Country
    US
    Email
    [email protected]
    Phone
    732 5373601

    Products

    Device Name Product Code
    Whole Slide Imaging System PSY

    Proprietary Names

    NanoZoomer S360MD Slide scanner system

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device