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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.

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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.

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