BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Leica Biosystems Imaging, Inc.

    Reg #: 3006791373 · FEI: 3006791373 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Leica Biosystems Imaging, Inc.
    Registration Number
    3006791373
    FEI Number
    3006791373
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1360 Park Center Drive
    City
    Vista
    State
    CA
    ZIP
    92081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252762

    Owner / Operator

    Firm Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Operator Number
    10054155
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    Postal Code
    60010
    Country
    US

    Products

    Device Name Product Code
    Digital Pathology Image Viewing And Management Software QKQ
    Whole Slide Imaging System PSY

    Proprietary Names

    Aperio HALO AP DX Aperio GT 450 DX

    Establishment Types

    Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device