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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252794

510(k) cleared

Vision-MR Diagnostic Catheter

Imricor Medical Systems, Inc. · Jan 8, 2026 · K252794

FDA cleared the Vision-MR Diagnostic Catheter from Imricor Medical Systems, Inc. on Jan 8, 2026 under K252794, a traditional 510(k). The device falls under product code DRF, Catheter, Electrode Recording, Or Probe, Electrode Recording, regulated at 21 CFR 870.1220 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 2, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Imricor Medical Systems, Inc. has 2 other decisions in the tracker over the last 12 months: K261119 (NorthStar Mapping System (MAP01 or MAP01-01)), K252164 (NorthStar Mapping System).

Questions & Answers

What did FDA clear under K252794?

K252794 is the FDA 510(k) for Vision-MR Diagnostic Catheter, submitted by Imricor Medical Systems, Inc.. FDA's decision date was Jan 8, 2026, under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording).

Who makes the Vision-MR Diagnostic Catheter?

Imricor Medical Systems, Inc., based in Burnsville, MN, is the applicant of record for K252794.

How long did the K252794 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Jan 8, 2026, 128 days later.

← All decisions in January 2026

Sources