510(k) K191877

FLUOROspeed by Shimadzu Corporation — Product Code JAA

K191877 is an FDA 510(k) premarket notification submitted by Shimadzu Corporation for the device "FLUOROspeed". The FDA issued a decision of Substantially Equivalent on August 5, 2019. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Shimadzu Corporation has at least 8 other 510(k) clearances on record.