510(k) K122427

CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE by Carestream Dental, LLC — Product Code LLZ

K122427 is an FDA 510(k) premarket notification submitted by Carestream Dental, LLC for the device "CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE". The FDA issued a decision of Substantially Equivalent on September 12, 2012. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.