510(k) K213637

JAZZ Solo sensor by Jazz Imaging, LLC Dba Jazz Imaging — Product Code MUH

K213637 is an FDA 510(k) premarket notification submitted by Jazz Imaging, LLC Dba Jazz Imaging for the device "JAZZ Solo sensor". The FDA issued a decision of Substantially Equivalent on Dec 10, 2021. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.