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510(k) Data Aggregation
(65 days)
UNIVERSAL SYSTEM, MODEL QV-800
The Quantum Medical Imaging, LLC Universal System is a stationary radiographic imaging system used for acquiring radiographic images of various anatomical regions of the human body.
The QV-800 Universal System is a walland floor-mounted column with an attached "swivel-arm". The QV-800 Universal System's "swivel-arm" design allows the x-ray tube and image receptor to remain in constant alignment as the arm is rotated and as the image receptor is anqulated. The QV-800 Universal System is designed for use in hospitals, imaging centers, and clinics.
The provided document is a 510(k) summary for the QV-800 Universal System, a stationary X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes for test/training sets, ground truth establishment, or expert involvement for AI/algorithmic performance evaluation.
The 510(k) summary focuses on the regulatory process of establishing substantial equivalence for a conventional medical device (an X-ray system) to legally marketed predicate devices, rather than on the performance evaluation of an AI-based or algorithmic device against specific acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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