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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 / K260318

510(k) cleared

4K NIR/ICG Imaging System

Zhejiang Healnoc Technology Co., Ltd. · May 26, 2026 · K260318

FDA cleared the 4K NIR/ICG Imaging System from Zhejiang Healnoc Technology Co., Ltd. on May 26, 2026 under K260318, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 30, 2026. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K260318?

K260318 is the FDA 510(k) for 4K NIR/ICG Imaging System, submitted by Zhejiang Healnoc Technology Co., Ltd.. FDA's decision date was May 26, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the 4K NIR/ICG Imaging System?

Zhejiang Healnoc Technology Co., Ltd., based in Hangzhou, is the applicant of record for K260318.

How long did the K260318 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on May 26, 2026, 116 days later.

← All decisions in May 2026