Table of Contents
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Preface
1.0
Intended Use
United States federal law restricts this device to use by, or on the order of, a physician.
The Affirm™ breast biopsy guidance system is an optional accessory for the Selenia®
Dimensions® digital mammography system. Its function is to localize lesions accurately
in the breast in three dimensions, using information extracted from stereotactic pairs of
two‐dimensional images. It is intended to provide targeting guidance for interventional
procedures such as biopsy, presurgical localization, or treatment devices.
2.0
Quality Control
Facilities that are ACR accredited must follow the 1999 Stereotactic Breast Biopsy Quality
Control Manual. Facilities that are not ACR accredited can follow the above manual or
perform the QAS Needle Test described in this manual at the required interval.
Part Number MAN-02866
Affirm Instructions for Use
Intended Use
Preface
xi
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