510(k) K013897

SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW by Bio-Scan S.A — Product Code MQB

K013897 is an FDA 510(k) premarket notification submitted by Bio-Scan S.A for the device "SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW". The FDA issued a decision of Substantially Equivalent on May 21, 2002. 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. Bio-Scan S.A has at least 6 other 510(k) clearances on record.