Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K161937
    Device Name
    CuattroDR
    Manufacturer
    Date Cleared
    2016-10-06

    (84 days)

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

    Cuattro, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CuattroDR, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
    Device Description
    The CuattroDR device is a software application capable of acquiring x-ray images from commonly commercialized digital flat panels on a Windows based computer workstation. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the CuattroDR software enables the user to use a traditional x-ray generator and capture x-rav images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival. In addition to this functionality, the CuattroDR software provides a user interface for generator control in the process of acquiring digital images.
    Ask a Question

    Ask a specific question about this device

    K Number
    K093480
    Device Name
    CUATTRO UNOMD
    Manufacturer
    Date Cleared
    2010-03-05

    (116 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUATTRO, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
    Device Description
    The Cuattro UnoMD software is a Windows based software application capable of acquiring x-ray images from commonly commercialized digital flat panels. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the software enables the user to use a separate traditional x-ray generator and capture x-ray images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1