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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 / June 2026 / K260820

510(k) cleared

VIVIX-S 4386W (FXRD-4386WA)

Vieworks Co., Ltd. · Jun 18, 2026 · K260820

FDA cleared the VIVIX-S 4386W (FXRD-4386WA) from Vieworks Co., Ltd. on Jun 18, 2026 under K260820, a special 510(k). The device falls under product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager), regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 13, 2026. The decision came 97 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: K254092 (Bellalun 2D (VDMS-1000S)), K251410 (VXvue).

Questions & Answers

What did FDA clear under K260820?

K260820 is the FDA 510(k) for VIVIX-S 4386W (FXRD-4386WA), submitted by Vieworks Co., Ltd.. FDA's decision date was Jun 18, 2026, under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Who makes the VIVIX-S 4386W (FXRD-4386WA)?

Vieworks Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K260820.

How long did the K260820 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Jun 18, 2026, 97 days later.

← All decisions in June 2026

Sources