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510(k) Data Aggregation

    K Number
    K002472
    Device Name
    DELTA 32 AND DELTA 32 TACT
    Manufacturer
    INSTRUMENTARIUM IMAGING, INC.
    Date Cleared
    2000-11-29

    (110 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTARIUM IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001928
    Device Name
    SIGMA
    Manufacturer
    INSTRUMENTARIUM IMAGING, INC.
    Date Cleared
    2000-08-02

    (37 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTARIUM IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000976
    Device Name
    DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
    Manufacturer
    INSTRUMENTARIUM IMAGING, INC.
    Date Cleared
    2000-06-01

    (66 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTARIUM IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001171
    Device Name
    DELTA 16 TACT
    Manufacturer
    INSTRUMENTARIUM IMAGING, INC.
    Date Cleared
    2000-05-12

    (31 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTARIUM IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K973642
    Device Name
    ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
    Manufacturer
    INSTRUMENTARIUM IMAGING, INC.
    Date Cleared
    1997-11-21

    (58 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTARIUM IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the surface of the dental arch and lateral images of the skull and lateral images of dentition, TM-joints using linear tomographic method.
    Device Description
    Not Found
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    K Number
    K955411
    Device Name
    DELTA 16
    Manufacturer
    INSTRUMENTARIUM IMAGING, INC.
    Date Cleared
    1996-03-21

    (115 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSTRUMENTARIUM IMAGING, INC.

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

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