510(k) K120975

CS 8100 CS 8100 ACCESS by Trophy — Product Code MUH

K120975 is an FDA 510(k) premarket notification submitted by Trophy for the device "CS 8100 CS 8100 ACCESS". The FDA issued a decision of Substantially Equivalent on June 22, 2012. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Trophy has at least 10 other 510(k) clearances on record.