510(k) K143537

Sirius Starmobile tiara by Hitachi Medical Systems America, Inc. — Product Code IZL

K143537 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "Sirius Starmobile tiara". The FDA issued a decision of Substantially Equivalent on March 6, 2015. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.