510(k) K133782

NOVA FA DR SYSTEM by Sedecal., Sa. — Product Code MQB

K133782 is an FDA 510(k) premarket notification submitted by Sedecal., Sa. for the device "NOVA FA DR SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 2014. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Sedecal., Sa. has at least 10 other 510(k) clearances on record.