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510(k) Data Aggregation

    K Number
    K192590
    Device Name
    CURA 778
    Date Cleared
    2020-03-05

    (167 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    FMI Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment supports, components and accessories. The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
    Device Description
    The CURA 778 scanner is a medical imaging device utilizing X-ray computed tomography (CT) to obtain images of the entire body. The CURA 778 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience. The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images. The CURA 778 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA 778 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only). The CURA 778 system is a stationary full gantry device. The gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilized to facilitate the transfer of electrical power and data between the gantry rotor and stator. The CURA 778 system software implements many of the CURA 778 Whole Body system scanner. Among the functions performed by the software are: - Entering and editing protocol, patient, and scan parameter data - Initiating scans, executing scan protocols, monitoring status, and responding to faults ● - Collecting image data and generating image views - Image viewing (3d reconstruction, MPR, CPR, MIP) - Image analysis (ROI) - Reporting and image filming - Exporting data for external viewing or printing - Performing calibrations - Performing diagnostics - Dose modulation feature (imA) - . Integrate a 30 party device for cardiac image processing, CREALIFE Anythink PACS Workstation, K131299 (510(k) number).
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    K Number
    K173076
    Device Name
    CURA 16; ScintCare CT16
    Date Cleared
    2018-10-04

    (370 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    FMI Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CURA CT16/ScintCare CT16 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment supports, components and accessories. The system is suitable for all patients.
    Device Description
    The CURA CT16/ScintCare CT16 computed tomography (CT) scanner is a medical imaging device utilizing X-ray computed tomography to obtain images of the entire body. The CURA CT16/ScintCare CT16 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience. The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images. The CURA CT16/ScintCare CT16 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA CT16/ScintCare CT16 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only). The CURA CT16/ScintCare CT16 system is a stationary full gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilitate the transfer of electrical power and data between the gantry rotor and stator. The CURA CT16/ScintCare CT16 system software implements many of the CURA CT16/ScintCare CT16 Whole Body system scanner. Among the functions performed by the software are: - Entering and editing protocol, patient, and scan parameter data - Initiating scans, executing scan protocols, monitoring status, and responding to faults - Collecting image data and generating image views - Image viewing (3d reconstruction, MPR, CPR, MIP) - Image analysis (ROI) - Reporting and image filming - Exporting data for external viewing or printing - Performing calibrations - Performing diagnostics - Metal artifact reduction is a capability of the system software, but is currently a future option. - Iterative reconstruction is a capability of the system software, but is currently a future option. - Dose modulation feature (imA) is a capability of the system software, but is currently a future option.
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