(27 days)
The Xplorer 1800 Digital Radiographic System with a universal stand for automatic delector positioning (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 heatto-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric palients. Applications can be performed with patient sitling, standing or lying in prone or supine positions.
The Xplorer 1800 (510k submission device) is not intended for mammography.
Not Found
This document is a letter from the FDA regarding a 510(k) premarket notification for the "Xplorer 1800 Digital Radiographic System with a universal stand for Automatic detector positioning." It primarily addresses regulatory approval and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The provided text serves as an FDA clearance letter and an "Indications for Use" statement, not a detailed technical report or a clinical study report. Therefore, I cannot extract the requested 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.