510(k) K031148

IN-VISION IMAGING SYSTEM by Jomed, Inc. — Product Code DXK

K031148 is an FDA 510(k) premarket notification submitted by Jomed, Inc. for the device "IN-VISION IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 28, 2003. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Jomed, Inc. has at least 8 other 510(k) clearances on record.