510(k) K112807

X-RAY VVA by Medis Medical Imaging Systems BV — Product Code LLZ

K112807 is an FDA 510(k) premarket notification submitted by Medis Medical Imaging Systems BV for the device "X-RAY VVA". The FDA issued a decision of Substantially Equivalent on February 27, 2012. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Medis Medical Imaging Systems BV has at least 10 other 510(k) clearances on record.