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The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

The CXD-DR80D Digital X-ray Imaging System utilizes the FLAATZ 750 Detector, manufactured by DRTECH Co. (K080064)

The digital X-ray imaging system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, a wall stand unit, a bucky table unit, a detector, operating software, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems.

The provided text is a 510(k) summary for a Digital X-ray Imaging System, CXD-DR80D. It describes the device, its intended use, and its substantial equivalence to predicate devices based on safety, EMC, and performance data.

However, it does not contain any information about acceptance criteria, detailed device performance metrics, or study designs that would typically involve sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone algorithm performance).

The summary primarily focuses on:

• Device Description: What the X-ray system is and how it works.
• Predicate Devices: Identifying similar devices already cleared by the FDA.
• Safety and Performance Testing: Stating that electrical, mechanical, environmental safety, and EMC testing were performed according to a list of EN/IEC standards and that results were satisfactory. This is a general statement about compliance with established standards, not a specific performance study with acceptance criteria.
• Indications for Use: What the device is approved for (generating radiographic images of human anatomy, not mammographic applications).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or describe a study that proves the device meets those criteria, as this information is not present. The document focuses on regulatory compliance through substantial equivalence to existing devices, primarily by meeting safety and EMC standards.

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