K122155 - PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
(FDA 510(k) Clearance)

K122155 is an FDA 510(k) clearance for the PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on September 4, 2012, 46 days after receiving the submission on July 20, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.