510(k) K182907

SPY Elite Intraoperative Perfusion Assessment System by Novadaq Technologies Ulc. (Now A Part of Stryker) — Product Code IZI

K182907 is an FDA 510(k) premarket notification submitted by Novadaq Technologies Ulc. (Now A Part of Stryker) for the device "SPY Elite Intraoperative Perfusion Assessment System". The FDA issued a decision of Substantially Equivalent on January 23, 2019. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Novadaq Technologies Ulc. (Now A Part of Stryker) has at least 5 other 510(k) clearances on record.