SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE

About This 510(k) Submission

K120882 is an FDA 510(k) clearance for the SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on May 30, 2012, 68 days after receiving the submission on March 23, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.