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This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

INFX-8000C, V6.20, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

The provided text describes modifications to an X-ray system (INFX-8000C, V6.20) and its substantial equivalence to a predicate device, rather than a study evaluating an AI-powered medical device against specific clinical acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI device cannot be extracted from this document.

The document primarily focuses on:

• Changes made to the device (flat panel detectors and C-arm support assembly).
• Compliance with regulatory standards and previous clearances.
• Confirmation that the modifications do not change the indications for use or raise new questions of substantial equivalence.

It does not contain information about an AI device or its performance study.

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