WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253584

510(k) cleared

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

Canon Medical Systems Corporation · Mar 10, 2026 · K253584

FDA cleared the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) from Canon Medical Systems Corporation on Mar 10, 2026 under K253584, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 17, 2025. The decision came 113 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), K253625 (Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR), K260078 (Aquilion ServeSP (TSX-307B) V2.0).

Questions & Answers

What did FDA clear under K253584?

K253584 is the FDA 510(k) for Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension), submitted by Canon Medical Systems Corporation. FDA's decision date was Mar 10, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)?

Canon Medical Systems Corporation, based in Otawara-Shi, is the applicant of record for K253584.

How long did the K253584 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 10, 2026, 113 days later.

← All decisions in March 2026