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510(k) Data Aggregation

    K Number
    K203703
    Device Name
    I-Q View
    Manufacturer
    Date Cleared
    2021-03-24

    (96 days)

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

    First Source, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This software is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications. This software is not meant for mammography, fluoroscopy, or angiography.
    Device Description
    The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol. The flat panel detector is not part of this submission. In the I-Q View software, the Digital Radiography Operator Console (DROC) software allows the following functions: - 1. Add new patients to the system; enter information about the patient and physician that will be associated with the digital radiographic images. - 2. Edit existing patient information. - 3. Emergency registration and edit Emergency settings. - 4. Pick from a selection of procedures, which defines the series of images to be acquired. - 5. Adiust technique settings before capturing the x-ray image. - 6. 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. - 7. Save an incomplete procedure, for which the rest of the exposures will be made at a later time. - 8. Close a procedure when all images have been captured. - 9. Review History images, resend and reprint images. - 10. Re-exam a completed patient. - 11. Protect patient records from being deleted by the system. - 12. Delete an examined Study with all images being captured. - 13. Edit User accounts. - 14. Check statistical information. - 15. Image QC. - 16. Image stitching. - 17. Provides electronic transfer of medical image data between medical devices.
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