(29 days)
The Xplorer 1590 Digital Radiographic System with motorized stand (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The Xplorer 1590 (510k submission device) is not intended for mammography.
Xplorer 1590 Digital Radiographic System with Motorized Stand
I am sorry, but the provided text does not contain the required information to describe the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for a device called "Xplorer 1590 Digital Radiographic System with Motorized Stand." It confirms the device's substantial equivalence to a predicate device but does not detail acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
§ 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.