(56 days)
The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked 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) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked 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 document is a 510(k) clearance letter for the Swissray Medical AG ddRFormula, indicating substantial equivalence to legally marketed predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's diagnostic accuracy or effectiveness.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process rather than specific performance data.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.