510(k) K150258

Vitrea, Version 7.0 Medical Image Processing Software by Vital Images, Inc. — Product Code LLZ

K150258 is an FDA 510(k) premarket notification submitted by Vital Images, Inc. for the device "Vitrea, Version 7.0 Medical Image Processing Software". The FDA issued a decision of Substantially Equivalent on March 5, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Vital Images, Inc. has at least 10 other 510(k) clearances on record.