Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193644
    Device Name
    E-COM DR-2000 DR
    Date Cleared
    2020-02-14

    (46 days)

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

    LiverMoreTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient. Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
    Device Description
    This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software: a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images. b. Edit existing patient information. c. Emergency registration and edit Emergency settings. d. Pick from a selection of procedures, which defines the series of images to be taken. e. Adjust technique settings before capturing the X-ray image. f. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations. g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time. h. Close a procedure when all images have been captured. i. Review History images, resend and reprint images. j. Re-exam a completed patient. k. Protect patient records from being deleted by the system. l. Delete an examined Study with all images being captured. m. Edit user accounts. n. Check statistical information. o. Image QC. p. Image stitching.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1