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510(k) Data Aggregation

    K Number
    K081522
    Device Name
    BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
    Manufacturer
    BIO NUCLEAR DIAGNOSTICS, INC.
    Date Cleared
    2008-12-05

    (189 days)

    Product Code
    HHT
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO NUCLEAR DIAGNOSTICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The (Endo)cervical Sampler is intended for the collection of endocervical cells for PAP smear analysis. This device is not intended for use in pregnant women.
    Device Description
    Not Found
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    K Number
    K021656
    Device Name
    HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
    Manufacturer
    NUCLEAR DIAGNOSTICS
    Date Cleared
    2002-06-13

    (24 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUCLEAR DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES HDAQ Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.
    Device Description
    The HERMES system consists of two components, a data acquisition station and a computer workstation. The HERMES HDAQ acquisition station and workstation are designed for use with commercially available gamma cameras. Software applications control acquisition, processing, display, analysis, and management of data and can be connected via network to other vendors' medical imaging workstations.
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    K Number
    K002782
    Device Name
    HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
    Manufacturer
    NUCLEAR DIAGNOSTICS AB
    Date Cleared
    2000-12-05

    (90 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    NUCLEAR DIAGNOSTICS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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