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FDA 510(k)

4K NIR/ICG Imaging System

K-Number: K260318 · 2026-05-26

ApplicantZhejiang Healnoc Technology Co., Ltd.
Decision Date2026-05-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4K NIR/ICG Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Healnoc Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K260318. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4K NIR/ICG Imaging System?

4K NIR/ICG Imaging System is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Zhejiang Healnoc Technology Co., Ltd.. The 510(k) number is K260318.

When did 4K NIR/ICG Imaging System receive FDA 510(k) clearance?

4K NIR/ICG Imaging System received FDA 510(k) clearance on 2026-05-26, under 510(k) number K260318.

Who is the listed applicant for 4K NIR/ICG Imaging System?

The FDA 510(k) record lists Zhejiang Healnoc Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4K NIR/ICG Imaging System?

The FDA product code for 4K NIR/ICG Imaging System is GCJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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