Hologic, Inc.

Software versions 5.0.x and 5.1.x

Radiology Devices

2

No

Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.

Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography

Serial Numbers: 1800314 7263, 180031472, 18002023051PR

Radiology Devices

2

No

Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.

Hologic M-IV Mammography System; Model M4--00001. || Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W

Radiology Devices

2

No

Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.

Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.