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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 / November 2025 / K251410

510(k) cleared

VXvue

Vieworks Co., Ltd. · Nov 4, 2025 · K251410

FDA cleared the VXvue from Vieworks Co., Ltd. on Nov 4, 2025 under K251410, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 7, 2025. The decision came 181 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Vieworks Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260820 (VIVIX-S 4386W (FXRD-4386WA)), K254092 (Bellalun 2D (VDMS-1000S)).

Questions & Answers

What did FDA clear under K251410?

K251410 is the FDA 510(k) for VXvue, submitted by Vieworks Co., Ltd.. FDA's decision date was Nov 4, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the VXvue?

Vieworks Co., Ltd., based in Anyang-Si, is the applicant of record for K251410.

How long did the K251410 review take?

FDA received the submission on May 7, 2025 and issued its decision on Nov 4, 2025, 181 days later.

← All decisions in November 2025

Sources