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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 / March 2026 / K253625

510(k) cleared

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation · Mar 27, 2026 · K253625

FDA cleared the Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR from Canon Medical Systems Corporation on Mar 27, 2026 under K253625, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 18, 2025. The decision came 129 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Canon Medical Systems Corporation has 8 other decisions in the tracker over the last 12 months: K253596 (Aquilion ONE (TSX-308A/TSX-306A) V2.0), K252503 (Intelligent NR), K260078 (Aquilion ServeSP (TSX-307B) V2.0), K253584 (Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)).

Questions & Answers

What did FDA clear under K253625?

K253625 is the FDA 510(k) for Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR, submitted by Canon Medical Systems Corporation. FDA's decision date was Mar 27, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR?

Canon Medical Systems Corporation, based in Otawara-Shi, is the applicant of record for K253625.

How long did the K253625 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 27, 2026, 129 days later.

← All decisions in March 2026