BEUDAMED
    Product Code: PSY FDA class 2 21 CFR 864.3700

    Whole Slide Imaging System

    Pathology

    The Whole Slide Imaging System is an automated digital pathology system that creates, views, and manages digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue, intended as an aid to pathologists reviewing and interpreting histological sections otherwise viewed by conventional brightfield microscopy. It is classified as FDA Class 2 under 21 CFR 864.3700 in the Pathology specialty, requiring 510(k) premarket notification. The system is not intended for frozen tissue, cytology, or non-FFPE hematopathology specimens. Product code PSY; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    19
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    10
    Years Active
    8

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    Basic Information

    Product Code
    PSY
    Device Class
    FDA class 2
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K243871 Philips IntelliSite Pathology Solution 5.1
    K241717 E1000 Dx Digital Pathology Solution
    K242783 Roche Digital Pathology Dx
    K242848 Philips IntelliSite Pathology Solution 5.1
    K241871 Philips IntelliSite Pathology Solution
    K233204 Philips IntelliSite Pathology Solution 5.1
    K232879 Roche Digital Pathology Dx (VENTANA DP 200)
    K232833 HALO AP Dx
    K232208 Sectra Digital Pathology Module (Version 3.3)
    K232202 Aperio GT 450 DX
    K230839 Concentriq Dx
    K233027 NanoZoomer S360MD Slide scanner system
    K213883 NanoZoomer S360MD Slide scanner system
    K203845 Philips IntelliSite Pathology Solution
    K203364 MDPC-8127
    K192259 Philips IntelliSite Pathology Solution
    K190332 Aperio AT2 DX System
    K172174 Philips IntelliSite Pathology Solution
    DEN160056 Philips IntelliSite Pathology Solution

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.