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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 / March 2026 / K260093

510(k) cleared

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

VATECH Co., Ltd. · Mar 31, 2026 · K260093

FDA cleared the Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) from VATECH Co., Ltd. on Mar 31, 2026 under K260093, a special 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 13, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for VATECH Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260093?

K260093 is the FDA 510(k) for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS), submitted by VATECH Co., Ltd.. FDA's decision date was Mar 31, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?

VATECH Co., Ltd., based in Hwaseong-Si, is the applicant of record for K260093.

How long did the K260093 review take?

FDA received the submission on Jan 13, 2026 and issued its decision on Mar 31, 2026, 77 days later.

← All decisions in March 2026