510(k) K163224

JAZZ SOLO Sensor by Jazz Imaging, LLC — Product Code MUH

K163224 is an FDA 510(k) premarket notification submitted by Jazz Imaging, LLC for the device "JAZZ SOLO Sensor". The FDA issued a decision of Substantially Equivalent on March 9, 2017. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Jazz Imaging, LLC has at least 1 other 510(k) clearance on record.