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 / October 2025 / K252074

510(k) cleared

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation · Oct 31, 2025 · K252074

FDA cleared the Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System from Canon Medical Systems Corporation on Oct 31, 2025 under K252074, 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 Jul 2, 2025. The decision came 121 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 K252074?

K252074 is the FDA 510(k) for Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System, submitted by Canon Medical Systems Corporation. FDA's decision date was Oct 31, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System?

Canon Medical Systems Corporation, based in Otawara-Shi, is the applicant of record for K252074.

How long did the K252074 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Oct 31, 2025, 121 days later.

← All decisions in October 2025