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510(k) Data Aggregation

    K Number
    K993962
    Device Name
    PENSIL TRAUMA, MODEL WWS6100
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1999-12-21

    (57 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pensil Trauma is a wall-mounted radiographic cassette holder device that is a 1110 Total Tradition 10 and position radiographic cassettes for a radiographic exposure for medical use.
    Device Description
    The Pensil Trauma is a wall-mounted radiographic cassette holder device.
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    K Number
    K992603
    Device Name
    XRT 600 R/F, WRF 0600
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1999-10-25

    (83 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.
    Device Description
    The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.
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    K Number
    K992103
    Device Name
    C-QUEST
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1999-09-01

    (71 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4R and 5 mobile x-ray unit with image intensifier system has been designed for diagnosis, suitable for x-ray and radioscopy, and radiography dedicated to: - Traumatology . - Paediatrics - Interventional radiology - Peace maker implantation - Operating theater - Intensive care . - Respiratory system ● - Skeleton . This device does not foresee any interaction with medicine, while the possibility of an interface with some devices like VCR or THERMAL PRINTER is foreseen.
    Device Description
    C-Quest 4R and 5 mobile x-ray unit with image intensifier system
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    K Number
    K981880
    Device Name
    DX-480, ADD ON DIGITAL IMAGER
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1998-10-20

    (145 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.
    Device Description
    The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.
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    K Number
    K974240
    Device Name
    LIGHTLINE-M
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1997-12-22

    (40 days)

    Product Code
    IZX
    Regulation Number
    892.1610
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.
    Device Description
    Not Found
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    K Number
    K955414
    Device Name
    XRT 400
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1996-07-24

    (240 days)

    Product Code
    KXJ
    Regulation Number
    892.1980
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960083
    Device Name
    MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1996-07-24

    (195 days)

    Product Code
    IXQ
    Regulation Number
    892.1980
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K935123
    Device Name
    SUPERSTAND 300
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1996-03-27

    (881 days)

    Product Code
    IYB
    Regulation Number
    892.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUESTEC MEDICAL, INC.

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

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