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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 / K260078

510(k) cleared

Aquilion ServeSP (TSX-307B) V2.0

Canon Medical Systems Corporation · Mar 13, 2026 · K260078

FDA cleared the Aquilion ServeSP (TSX-307B) V2.0 from Canon Medical Systems Corporation on Mar 13, 2026 under K260078, 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 Jan 12, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

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), K253584 (Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)).

Questions & Answers

What did FDA clear under K260078?

K260078 is the FDA 510(k) for Aquilion ServeSP (TSX-307B) V2.0, submitted by Canon Medical Systems Corporation. FDA's decision date was Mar 13, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Aquilion ServeSP (TSX-307B) V2.0?

Canon Medical Systems Corporation, based in Tustin, CA, is the applicant of record for K260078.

How long did the K260078 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Mar 13, 2026, 60 days later.

← All decisions in March 2026