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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 / K253597

510(k) cleared

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation · Jan 20, 2026 · K253597

FDA cleared the Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System from Canon Medical Systems Corporation on Jan 20, 2026 under K253597, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 18, 2025. The decision came 63 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), K260078 (Aquilion ServeSP (TSX-307B) V2.0).

Questions & Answers

What did FDA clear under K253597?

K253597 is the FDA 510(k) for Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System, submitted by Canon Medical Systems Corporation. FDA's decision date was Jan 20, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System?

Canon Medical Systems Corporation, based in Otawara-Shi, is the applicant of record for K253597.

How long did the K253597 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Jan 20, 2026, 63 days later.

← All decisions in January 2026