510(k) K162619

I View and Imagen Sensor by Trident S.R.L — Product Code MUH

K162619 is an FDA 510(k) premarket notification submitted by Trident S.R.L for the device "I View and Imagen Sensor". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Trident S.R.L has at least 4 other 510(k) clearances on record.