Radiation-Emitting Products

Is there a list that shows the laser printers that have been cleared for mammography by the FDA? If not, how can I determine if FDA has cleared a given laser printer for mammography use?

Policy Guidance Help System logo

No.  Although FDA has cleared many printers for FFDM use through the 510(k) process, FDA does not keep a list of cleared printers, other than what is available in FDA’s 510(k) database at http://www.fda.gov/cdrh/510khome.html#database. You can search this database by product code, device name, applicant name, decision date, and other elements, including a simple word search. Another way to find out whether a particular printer has been cleared for FFDM use is to check the device’s labeling or to have the printer manufacturer provide you with written documentation showing that the printer has been cleared by FDA for FFDM.

Back to Other Modalities Quality Control Tests

Page Last Updated: 07/25/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.