510(k) K071037

SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 by Novadaq Technologies, Inc. — Product Code IZI

K071037 is an FDA 510(k) premarket notification submitted by Novadaq Technologies, Inc. for the device "SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000". The FDA issued a decision of Substantially Equivalent on May 10, 2007. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Novadaq Technologies, Inc. has at least 10 other 510(k) clearances on record.