510(k) K252794

Vision-MR™ Diagnostic Catheter by Imricor Medical Systems, Inc. — Product Code DRF

K252794 is an FDA 510(k) premarket notification submitted by Imricor Medical Systems, Inc. for the device "Vision-MR™ Diagnostic Catheter". The FDA issued a decision of Substantially Equivalent on January 8, 2026. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Imricor Medical Systems, Inc. has at least 2 other 510(k) clearances on record.