510(k) K231986

Modus IR by Synaptive Medical, Inc. — Product Code IZI

K231986 is an FDA 510(k) premarket notification submitted by Synaptive Medical, Inc. for the device "Modus IR". The FDA issued a decision of Substantially Equivalent on March 25, 2024. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Synaptive Medical, Inc. has at least 9 other 510(k) clearances on record.