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Special 510(k) Premarket Notification GE Healthcare GE Vivid E9 Ultrasound July 2, 2008, AUG 6 2008 Attachment B: Summary of Safety and Effectiveness Prepare din accordance with 21 CFR Part807.92(c).
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GE Healthcare -GE Vivid is a healthcare technology company that specializes in medical imaging equipment and software.
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Healthcare facilities and providers who use GE Healthcare's Vivid products are required to file GE Healthcare -GE Vivid.
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To fill out GE Healthcare -GE Vivid, users must gather all necessary information about the medical imaging equipment and software used in their facility and submit the required forms online or through GE Healthcare's designated channels.
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The purpose of GE Healthcare -GE Vivid is to collect data on the usage of GE Healthcare's medical imaging equipment and software in healthcare facilities for regulatory and business purposes.
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Information that must be reported on GE Healthcare -GE Vivid includes details on the type of GE Healthcare products used, the number of patients served, and any issues or concerns related to the equipment.
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