FDA-Device2014-12-24Class II
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Carestream Health, Inc.
Hazard
Reduced mammographic image quality when attempting to print true size multi-format images
Sold states
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.
Affected count
59 units
Manufactured in
1049 W Ridge Rd, N/A, Rochester, NY, United States
Products
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0820-2015Don't want to check this manually?
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