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510(k) Data Aggregation

    K Number
    K040057
    Device Name
    MOBILE COMPACT DIGITAL CARDIAC CAMERA
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    2004-02-02

    (20 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mobile Compact Digital Cardiac (MCDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.
    Device Description
    The Mobile Compact Digital Cardiac Camera (MCDCC) is a gamma camera system. It includes a detector head, gantry, and resides on a mobile platform. It includes accessories such as signal analysis and display equipment supports, radionuclide anatomical markers, component parts and accessories.
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    K Number
    K033956
    Device Name
    MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    2004-01-20

    (29 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.
    Device Description
    The Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Mobile Single Rectangular Camera (MSR). The detector head is identical in hardware and software. The gantry of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) are optimised for being attached to a mobile platform which is transported from location to location in a truck and have the same range of automatic clinical motions of Mobile Single Rectangular Cumera (MSR).
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    K Number
    K032779
    Device Name
    MODIFICATION TO: NUCAMMA RX
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    2003-12-17

    (100 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories. To detect or image the distribution of radionuclides in the body or organ using the following technique(s); (a) Planar Imaging (b) Whole Body Imaging (c) Tomographic Imaging (SPECT) for non Positron emitter (d) Positron imaging by coincidence (e) Positron imaging without coincidence (f) Other indication(s) in the device label, but not included in the above list None
    Device Description
    The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads. The intended use of the Mobile Rectangular Single Head Camera (MSR) is the same range of studies to that of the Rectangular Single Head Camera (SR). The detector head is identical in hardware and software. The gantry of the Mobile Rectangular Single Head Camera (MSR) is optimized for being attached to a mobile platform which is transported from location in a truck and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR).
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    K Number
    K013667
    Device Name
    BCC GAMMA CAMERA
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    2002-01-28

    (83 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To DETECT AND IMAGE THE DISTRIBUTION of THE GAMMA EMITTING RADIONUCLIDE IN THE PATIENT 'S BREAST AND THE SURROUNDING AREA AND TO STORE THE IMAGES WHEN THE RADIONUCLIPE IS ADMINISTERED INTO THE PATIENT 'S Bo Dy-THE
    Device Description
    The BCC nuclear imaging system has two rectangular fields of view detector heads.
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    K Number
    K003882
    Device Name
    NUCAMMA BI90
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    2001-02-21

    (68 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982044
    Device Name
    NUCAMMA R+
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    1998-09-02

    (84 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): Planar Imaging, Whole Body Imaging, Tomographic imaging (SPECT) for non Positron emitter.
    Device Description
    The NuCamma R* nuclear imaging system has a round field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.
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    K Number
    K982045
    Device Name
    NUCAMMA RX
    Manufacturer
    IS2 RESEARCH, INC.
    Date Cleared
    1998-09-02

    (84 days)

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

    IS2 RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): A. Planar Imaging B. Whole Body Imaging C. Tomographic imaging (SPECT) for non Positron emitter
    Device Description
    The NuCamma Rx nuclear imaging system has a rectangular field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.
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