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The Xplorer 1600 Plus is intended for use by a qualified/trained doctor or technologist on both adult and pediatric palients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.

The Xplorer 1600 Plus (510k submission device) is not intended for mammography.

Xplorer 1600 Plus digital radiographic system

This document is a 510(k) clearance letter from the FDA for a medical device called the "Xplorer 1600 Plus Digital Radiographic System." It does not contain sections on acceptance criteria or detailed study information typically found in a clinical study report. Therefore, I cannot extract the requested information from the provided text.

Specifically, the document:

• Identifies the device: Xplorer 1600 Plus Digital Radiographic System.
• States its intended use: Taking diagnostic radiographic exposures of various body parts in adult and pediatric patients (excluding mammography).
• Confirms regulatory clearance: Substantial equivalence to a legally marketed predicate device.
• Outlines general regulatory requirements.

This type of FDA letter confirms market clearance based on substantial equivalence to an existing device, rather than providing the detailed performance studies and acceptance criteria that you've asked for. Such information would typically be found in the 510(k) submission itself or a separate scientific report.

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The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.

A stationary x-ray system with CCD imager

This is a 510(k) clearance letter for an X-ray system, specifically the Xplorer 1600. The provided document is a letter from the FDA regarding substantial equivalence and the "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

Ask a specific question about this device