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The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRCompact is a further development of the AddOn Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRCompact is configured with a one CCD X-ray detector (HD-3000) and is designed for applying general radiography and orthopaedic examinations on a patient in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

The provided text is a 510(k) premarket notification letter from the FDA to Swissray Medical AG for their ddRCompact device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of comparative effectiveness studies (MRMC) or standalone performance studies.

The letter is a regulatory approval document and focuses on:

• Confirming the device name (ddRCompact) and regulatory classification (Class II).
• Stating that the device is substantially equivalent to predicate devices.
• Outlining the general controls provisions of the Act that the manufacturer must comply with.
• Providing contact information for regulatory advice.
• Including the "Indications for Use" for the device, which describes its intended purpose and settings.

To provide the detailed information requested in your prompt, a different type of document, such as a clinical study report, a technical performance report, or detailed sections from the 510(k) submission itself (beyond the summary provided here), would be required.

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