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510(k) Data Aggregation

    K Number
    K081829
    Device Name
    CAPIMAGE
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2008-07-11

    (14 days)

    Product Code
    IYX
    Regulation Number
    892.1100
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    Applicant Name (Manufacturer) :

    DANISH DIAGNOSTIC DEVELOPMENT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CapIMAGE Gamma Camera System is intended to produce planar images depicting the anatomical distributions of single photon emitting radioisotopes in the human body within the energy range of 59kev to 167kev. The system provides software applications for processing, analyzing, and displaying medical images for interpretation by medical personnel. The CapIMAGE Gamma Camera System is intended for examination (and diagnosis) of disorders and diseases in the thyroid gland, the heart and other small organs. The device is not interpretative. Data from the device are interpreted by medical personnel who, based on these, make the clinical diagnosis.
    Device Description
    The CapIMAGE is a mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays. The CapIMAGE is designed to be manually transported and deployed for scanning of patients in laying, sitting or standing positions. The system can operate powered from mains or from the internal battery source for at least 60 min.
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    K Number
    K051460
    Device Name
    C.CAM-AC
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2005-06-15

    (12 days)

    Product Code
    KPS
    Regulation Number
    892.1200
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    Applicant Name (Manufacturer) :

    DANISH DIAGNOSTIC DEVELOPMENT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body. The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure the attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.
    Device Description
    The c.cam-AC is an attenuation correction device, which will be marketed as an optional device for the c.cam gamma camera. C.cam gamma camera is a dual detector system and the attenuation correction device (two units) will be mounted opposite of the two detectors, one device on each detector. The attenuation correction device is formed as two housings each containing 14 line sources in fixed positions, shutter and all shutter control. The following described functions are performed on both detectors simultaneously. When the scanning is initiated the emission image and the transmission images are acquired sequentially. When the emission image has been acquired, a shutter, common for all sources, located in the device housing will open for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total of max. 96 mCi). A collimated beam of gamma ray photons is focused on the opposite detector field of view to create the transmission images of the patient placed in the field of view of the detector. Having acquired both emission and transmission images, the data for emission, transmission, emission scatter and transmission scatter are stored in one dataset. A scaled version of the blank transmission scan is stored in another dataset. The complete study can be export via DICOM to the OEM customer provided processing station for later processing and reviewing.
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    K Number
    K040616
    Device Name
    CARDIOMD-AC
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2004-03-24

    (15 days)

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

    DANISH DIAGNOSTIC DEVELOPMENT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body. The intended use of the CardioMD-AC Attenuation Correction option is to provide the costumer with means to measure the attenuation of gamma rays within the body of a patient, when using a DDD CardioMD gamma camera system type 9CSY0799 for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The CardioMD-AC includes additional acquisition of data for scatter correction of these images.
    Device Description
    Not Found
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    K Number
    K031825
    Device Name
    C.CAM
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2003-06-20

    (7 days)

    Product Code
    KPS
    Regulation Number
    892.1200
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    Applicant Name (Manufacturer) :

    DANISH DIAGNOSTIC DEVELOPMENT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment parts, and accessories. Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 -170 keV
    Device Description
    The Virgo system design comprises a gantry supporting a fixed 90 degree dual head detector and a patient chair. The Virgo system is operated through interaction with a graphical user interface situated on the acquisition PC and a dedicated Virgo hand controller.
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    K Number
    K011611
    Device Name
    CARDIOCAM MODEL 9CSY0799
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2001-06-08

    (14 days)

    Product Code
    KPS
    Regulation Number
    892.1200
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    Applicant Name (Manufacturer) :

    DANISH DIAGNOSTIC DEVELOPMENT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, intages are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, Tl-201, Co-57.
    Device Description
    The Cardiocam system is a dual head system designed to acquire data for cardiat multi-slice images.
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    K Number
    K001888
    Device Name
    UNICORN MODEL SYS0630
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2000-06-30

    (15 days)

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

    DANISH DIAGNOSTIC DEVELOPMENT A/S

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