CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Reason: Reduced mammographic image quality when attempting to print true size multi-format images

Code information: Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031

Distribution pattern: Worldwide Distribution: US distribution to states of : NY, OH, and NC; and countries of: Argentina, Brazil, China, Chile, Colombia, France, Greece, Hong Kong, India, Japan, Korea, Mexico, Peru, Spain, Taiwan, and Thailand.