Kodak DryView 8900 manual Control and the QC, Process, Requirements, Laser Imager

Appendix A: Quality Control Procedures

Compliance Guide - Quality Control for Laser Imagers Used in Digital Mammography Systems

	These Quality Control Procedures are intended to provide guidance for
	mammography facilities and their personnel. They represent the equipment
	manufacturer’s views on the appropriate procedures for conducting Quality
	Control tests for digital mammography and observing the Mammography
	Quality Standards Act (MQSA). The following procedures represent
	acceptable ways of doing the tests, but unlike regulations, they are not
	binding. Alternate procedures may be used if they satisfy the requirements
	of the applicable statute, regulations or both. It is the responsibility of the
	mammography facility to read, understand and follow the regulations.
	Under its own authority, a state may impose requirements more stringent
	than those imposed in the FDA Mammography Quality Standards Act. A
	facility should check with state or local authorities regarding their
	requirements.
Automatic Image Quality	The Kodak DryView 8900 Laser Imager has a built-in Automatic Image
Control and the QC	Quality Control (AIQC) system that automatically compensates for film lot
Process	variations, ensuring consistent print densities. The MQSA requires that the
	mammography facility establish a quality control (QC) process that verifies
	the effectiveness of the AIQC system. Kodak's recommendations below are
	based on the MQSA and the QC process described in the Radiologic
	Technologist's Section of the Mammography Quality Control Manual, 1999,
	published by the American College of Radiology. This QC process has been
	adapted to apply to the special features of Kodak DryView Mammography
	Laser Imaging Film and the characteristics of the 8900 Laser Imager. The
	procedures that follow assume that the user has been trained in operation
	of the 8900 Laser Imager.

January 10, 2006 5E6155 A-1