4K NIR/ICG成像系統
K 號：K260318 · 2026-05-26
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：GCJ）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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