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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 / May 2026 / K253596

510(k) cleared

Aquilion ONE (TSX-308A/TSX-306A) V2.0

Canon Medical Systems Corporation · May 20, 2026 · K253596

FDA cleared the Aquilion ONE (TSX-308A/TSX-306A) V2.0 from Canon Medical Systems Corporation on May 20, 2026 under K253596, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 18, 2025. The decision came 183 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: 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), K253584 (Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)).

Questions & Answers

What did FDA clear under K253596?

K253596 is the FDA 510(k) for Aquilion ONE (TSX-308A/TSX-306A) V2.0, submitted by Canon Medical Systems Corporation. FDA's decision date was May 20, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Aquilion ONE (TSX-308A/TSX-306A) V2.0?

Canon Medical Systems Corporation, based in Otawara-Shi, is the applicant of record for K253596.

How long did the K253596 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on May 20, 2026, 183 days later.

← All decisions in May 2026