510(k) K052422

THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) by Flow X-Ray Corp. — Product Code EAP

K052422 is an FDA 510(k) premarket notification submitted by Flow X-Ray Corp. for the device "THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)". The FDA issued a decision of Substantially Equivalent on September 27, 2005. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Flow X-Ray Corp. has at least 1 other 510(k) clearance on record.