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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 / September 2025 / K251645

510(k) cleared

Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

Canon Medical Systems Corporation · Sep 26, 2025 · K251645

FDA cleared the Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP from Canon Medical Systems Corporation on Sep 26, 2025 under K251645, 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 May 29, 2025. The decision came 120 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 K251645?

K251645 is the FDA 510(k) for Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP, submitted by Canon Medical Systems Corporation. FDA's decision date was Sep 26, 2025, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP?

Canon Medical Systems Corporation, based in Otawara-Shi, is the applicant of record for K251645.

How long did the K251645 review take?

FDA received the submission on May 29, 2025 and issued its decision on Sep 26, 2025, 120 days later.

← All decisions in September 2025