510(k) K931815

2000 X-RAY - TOMOGRAPHIC by Imaging Sciences Intl., Inc. — Product Code IZF

K931815 is an FDA 510(k) premarket notification submitted by Imaging Sciences Intl., Inc. for the device "2000 X-RAY - TOMOGRAPHIC". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Imaging Sciences Intl., Inc. has at least 6 other 510(k) clearances on record.