SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T

About This 510(k) Submission

K974457 is an FDA 510(k) clearance for the SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on July 14, 1998, 231 days after receiving the submission on November 25, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.