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510(k) Data Aggregation

    K Number
    K220684
    Device Name
    Oryx Cloud Imaging
    Date Cleared
    2022-04-29

    (52 days)

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

    Oryx Dental Software INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Oryx Cloud Imaging is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.
    Device Description
    Oryx Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any Mac or PC with an active internet connection. Oryx Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. Oryx Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. Oryx Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using Oryx Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files. Oryx Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors, intraoral cameras, and scanners. Oryx Cloud Imaging is imaging software designed for use in dentistry. The main Oryx Cloud Imaging software functionality includes image acquisition, organization. Oryx Cloud Imaging is used by dental professionals for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Dentists and other qualified individuals can display and review images, apply annotations, and manipulate images. Oryx Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing. The software operates upon standard PC hardware and displays images on the PC's connected display/monitor. The subject device is the Oryx PACS software; the computer or the monitor are not part of the submission.
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