MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE

About This 510(k) Submission

K053042 is an FDA 510(k) clearance for the MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on November 17, 2005, 20 days after receiving the submission on October 28, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.