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The OnePacs system may be used to store, transfer and transfer view mammography images. However, the OnePacs system does not currently provide an approved viewer for mammographic images. Users may use an approved Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. Mammographic images should only be viewed with a monitor approved by FDA for viewing Mammographic images. It is the user’s responsibility to ensure monitor quality, ambient light conditions and that image compression ratios are consistent with clinical application.
Users may also use an approved 3rd party mammography viewing system in association with approved mammography display devices in conjunction with the OnePacs system for interpreting mammographic studies.
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