510(k) K190809

Sample Imaging for Senographe Pristina by GE Healthcare — Product Code MUE

K190809 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Sample Imaging for Senographe Pristina". The FDA issued a decision of Substantially Equivalent on Jul 29, 2019. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. GE Healthcare has 168 other 510(k) clearances on record.