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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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The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class II (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms.

The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position.

The major system components are:

fix height adjustable patient table, X-ray generator, X-ray tube, Collimator, stand, ceiling suspension, digital AddOn bucky (4 CCD cameras), Image processing software and monitors.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format. The document appears to be a 510(k) screening checklist and an FDA clearance letter for a device called "ddRCombi TRAUMA," an X-ray system.

While it mentions "Performance data : bench data," "Animal data," and "Clinical data" in the checklist, and that clinical data was present, it does not provide any specific details about:

• Acceptance criteria: What specific performance metrics were targeted (e.g., sensitivity, specificity, resolution, contrast, MTF values).
• Reported device performance: The actual outcomes of any tests against those criteria.
• Study details: Sample sizes, data provenance, number of experts, adjudication methods, MRMC study results, standalone performance, or ground truth establishment for either test or training sets.

The document primarily focuses on regulatory compliance aspects and technical specifications of the device from a manufacturing and classification standpoint, rather than a clinical performance study report.

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The Swissray Tellerav AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipuroose or dedicatedapplications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position.

The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.

This document is a 510(k) clearance letter from the FDA for a device called "Digital Addon Multi System, Stationary X-Ray System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text DOES NOT contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory approval letter, not a scientific study report. It mentions the "indications for use" of the device, but it does not detail any performance metrics, studies, or criteria for acceptance that were tested.

Therefore, I cannot provide a response filling in the requested table and details because that information is not present in the given input.

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