The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.
Intended Use
The uDR 780i Digital Medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.
Technology
The system includes a Tube Ceiling Suspension with tube and collimator, Bucky Wall Stand, Elevating Table, High Voltage Generator, wireless flat panel detectors, and an acquisition workstation. It generates digital images which can be transferred through a DICOM network for printing, review, and storage. The detectors use amorphous silicon with cesium iodide scintillators. It employs software for import/export, image viewing, measurement, annotation, and post-processing.
Performance
Non-clinical tests verified compliance with design specifications and international standards including ANSI/AAMI ES 60601-1 series, IEC 60601 series for safety, performance, EMC, and radiation protection. Clinical image evaluation with a certified radiologist confirmed image quality sufficient for diagnosis across multiple anatomical sites.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/19/2024
6 months - 2
FDA Approval
11/1/2024
Other devices from Shanghai United Imaging Healthcare Co., Ltd.
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
- uMI Panvivo2024 • 510K
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