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The Philips NICOL Collimator is intended for use in diagnostic x-ray systems during radiographic and fluoroscopic examinations. The collimator restricts the dimensions of the diagnostic x-ray field by limiting the size of the primary x-ray beam.

The NICOL collimator family of Beam Limiting Devices which may be used in all Philips Radiographic, Universal Radiographic/Fluoroscopic, Cardio and Vascular systems. It will provide rectangular shuttering, circular shuttering, or a combination of both. It will provide a light simulation of the X-ray field, spectral filtering, wedge filtering, dose measurement, and mechanical or electronic SID measurement.

This document is a 510(k) summary for the Philips NICOL Collimator Family. It provides information about the device's intended use and compliance with safety standards, but it does not contain details about acceptance criteria, specific device performance metrics, or any studies involving test sets, ground truth establishment, or human reader performance.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission summary, not a clinical or performance study report.

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