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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 / May 2026 / K254092

510(k) cleared

Bellalun 2D (VDMS-1000S)

Vieworks Co., Ltd. · May 28, 2026 · K254092

FDA cleared the Bellalun 2D (VDMS-1000S) from Vieworks Co., Ltd. on May 28, 2026 under K254092, a traditional 510(k). The device falls under product code MUE, Full Field Digital, System, X-Ray, Mammographic, regulated at 21 CFR 892.1715 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 19, 2025. The decision came 160 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)), K251410 (VXvue).

Questions & Answers

What did FDA clear under K254092?

K254092 is the FDA 510(k) for Bellalun 2D (VDMS-1000S), submitted by Vieworks Co., Ltd.. FDA's decision date was May 28, 2026, under product code MUE (Full Field Digital, System, X-Ray, Mammographic).

Who makes the Bellalun 2D (VDMS-1000S)?

Vieworks Co., Ltd., based in Anyang-Si, is the applicant of record for K254092.

How long did the K254092 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 28, 2026, 160 days later.

← All decisions in May 2026

Sources