510(k) K221955

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 by Realcloud Imaging Inc. Dba Realcloud Imaging — Product Code MUH

K221955 is an FDA 510(k) premarket notification submitted by Realcloud Imaging Inc. Dba Realcloud Imaging for the device "Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20". The FDA issued a decision of Substantially Equivalent on August 31, 2022. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.