4K NIR/ICG Imaging System— 510(k) K260318

Name: FDA 510(k) clearance K260318
Creator: U.S. Food and Drug Administration
Published: 2026-05-26

Substantially Equivalent

Zhejiang Healnoc Technology Co., Ltd.

FDA 510(k) clearance K260318 for 4K NIR/ICG Imaging System, Substantially Equivalent on 2026-05-26. Applicant: Zhejiang Healnoc Technology Co., Ltd.. Device class: 2.

Summary

Zhejiang Healnoc Technology filed the 4K NIR/ICG Imaging System under GCJ, general and plastic surgery laparoscopes. The record doesn't expand "NIR" or "ICG".

Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.

Healnoc filed from Hangzhou, China. The decision came 116 calendar days after receipt (January 30 to May 26, 2026).

Clearance details

Applicant: Zhejiang Healnoc Technology Co., Ltd.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-01-30
Decision date: 2026-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.