510(k) K190772

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR by Olympus Medical Systems Corp. — Product Code IZI

K190772 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "SURGICAL MICROSCOPE SYSTEM ORBEYE with IR". The FDA issued a decision of Substantially Equivalent on Oct 10, 2019. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.