BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dynamyx Digital Pathology Software

    DI: 00860007120206 · Model: 2.4 · OMNYX, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dynamyx Digital Pathology Software
    Primary DI
    00860007120206
    Version / Model
    2.4
    Company Name
    OMNYX, LLC
    Labeler DUNS
    002116917
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-21
    Public Version
    1
    Public Version Date
    2022-04-29
    Public Version Status
    New
    Public Device Record Key
    54f00c3e-84e4-4b3b-8b48-025cdee654c7

    Device Description

    Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QKQ Digital Pathology Image Viewing And Management Software

    GMDN Terms

    Code Name
    44103 Pathology information system application software

    Identifiers

    Type ID
    Primary 00860007120206