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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 / October 2025 / K250060

510(k) cleared

GT300; GT300-C

Genoray Co., Ltd. · Oct 8, 2025 · K250060

FDA cleared the GT300; GT300-C from Genoray Co., Ltd. on Oct 8, 2025 under K250060, a traditional 510(k). The device falls under product code OAS, X-Ray, Tomography, Computed, Dental, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 10, 2025. The decision came 271 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Genoray Co., Ltd. has one other decision in the tracker over the last 12 months: K252229 (BELLIGER ACE).

Questions & Answers

What did FDA clear under K250060?

K250060 is the FDA 510(k) for GT300; GT300-C, submitted by Genoray Co., Ltd.. FDA's decision date was Oct 8, 2025, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the GT300; GT300-C?

Genoray Co., Ltd., based in Seongnam-Si, is the applicant of record for K250060.

How long did the K250060 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Oct 8, 2025, 271 days later.

← All decisions in October 2025

Sources