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510(k) Data Aggregation

    K Number
    K200822
    Device Name
    Braid
    Manufacturer
    Date Cleared
    2020-08-13

    (136 days)

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

    Braid.Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Braid is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices. Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace workstations and should only be used when there is no access to a workstation. Braid mobile diagnostic use is not intended for the display of mammography images for diagnosis. When images are reviewed and use as an element of diagnosis, it is the trained physician to determine if the image quality is suitable for their clinical application. Contraindications: Braid is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
    Device Description
    Braid is a web-based software platform that allows a user to view DICOM-compliant images for diagnostic and mobile-diagnostic purposes. Braid may be used with FDA-cleared diagnostic monitors and mobile devices including iPhones, and iPads . It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, and review of reports and demographic information. Braid allows for multispecialty viewing of medical images including Computed Radiography (CR), Computer Tomography (CT), Digital Radiography (DX), Magnetic Resonance (MR), as well as associated non-imaging data such as report text. - . Braid can be used for primary diagnosis on FDA-cleared diagnostic monitors. Braid is intended for use by trained and instructed healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to review patient images, perform non-destructive manipulations, annotations, and measurements. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application. - . Braid can also be used for reference and diagnostic viewing on mobile devices. Braid diagnostic use on mobile devices is not intended to replace full diagnostic workstations and should only be used only be used for when there is no access to workstation. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application. Braid has the following viewer technology and features: - Grayscale Image Rendering - Localizer Lines - Localizer Point - Orientation Markers - Distance Markers - Study Data Overlays - Stack Navigation Tool - Window/Level Tool - Zoom Tool - Panning Tool - Color Inversion - Text Annotation - Maximum Intensity Projection - Reslicing (MPR) - Area Measurement Annotation - Angle Measurement Annotation In addition, Braid has: - Added Hardware accelerated rendering - Support for high resolution Retina displays - Keyboard shortcuts for all tools and all annotation types - Touchscreen support - Quick image manipulation and navigation via multitouch gestures, on touchscreens or multitouch capable trackpads
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