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Quality Control Manual - hologic.com

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Quality Control Manual Selenia Dimensions DM. Selenia Dimensions BT. Part Number MAN-01965. Revision 010. January 2016. Selenia Dimensions System Quality Control Manual Table of Contents Table of Contents 1: Prologue ________________________________________ _____________________________1. Introduction ........................................ ........................................ ........................................ ..................................... 1. Intended Use of the Selenia Dimensions Quality Control Manual ........................................ .......................... 1. How to Use the Quality Control Manual ........................................ ........................................ ............................ 2. Prerequisites ........................................ ........................................ ........................................ .................................... 3. Change Summary.

Quality Control Manual may jeopardize their FDA/MQSA certification. The MQSA Final Regulations mandate that the recommended QA/QC program for the Selenia Dimensions system must be maintained in addition to the existing Quality Assurance and Quality Control programs for screen-film mammography.

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