510(k) K061284

I-CAT SCANNER by Imaging Sciences Intl., Inc. — Product Code MUH

K061284 is an FDA 510(k) premarket notification submitted by Imaging Sciences Intl., Inc. for the device "I-CAT SCANNER". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Imaging Sciences Intl., Inc. has at least 6 other 510(k) clearances on record.