(310 days)
The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations.
The Digital Add-on Bucky system allows the operator to view and enhance the images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The Add-on Bucky system enables the operator to hardcopy images with a laser printer.
The major system components include: a CCD camera, monitors and an image processor.
I am sorry, but the provided text does not contain the acceptance criteria or a study proving device performance as requested. The document is a 510(k) clearance letter from the FDA for a device called "Swissary Telleray AG Digital Add-on Bucky System." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information and contact details. It does not include specific performance metrics, study details, or ground truth information.
§ 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.