Radiation-Emitting Products

Are we required to use a specific type of laser film when printing full field digital images?

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While there is a requirement in 21 CFR 900.12(b)(11) that the x-ray film used for screen-film mammography be designated as appropriate for mammography, there is no similar requirement for the laser film used to print full field digital mammography hardcopy images. However, FDA recommends that facilities use laser film compatible with the printer being used, and designated for FFDM use by the laser film manufacturer or recommended by the FFDM manufacturer. Under 21 CFR 900.12(e)(6), laser film used for hardcopy must produce images of final interpretation quality that pass the applicable QC tests listed in the FFDM manufacturer’s QC manual.


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Page Last Updated: 06/23/2014
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