510(k) K202244

SPY-PHI System with SPY-PHI Fluorescence Assessment Software by Novadaq Technologies Ulc. (Now A Part Of Stryker) — Product Code OWN

K202244 is an FDA 510(k) premarket notification submitted by Novadaq Technologies Ulc. (Now A Part Of Stryker) for the device "SPY-PHI System with SPY-PHI Fluorescence Assessment Software". The FDA issued a decision of Substantially Equivalent on Nov 5, 2020. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Novadaq Technologies Ulc. (Now A Part Of Stryker) has at least 5 other 510(k) clearances on record.