SKOUT系統
K 號：K251126 · 2025-05-09
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器材摘要
SKOUT system is the device name listed in this FDA 510(k) record. The listed applicant is Iterative Health. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K251126. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SKOUT system?
SKOUT system is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Iterative Health. The 510(k) number is K251126.
When did SKOUT system receive FDA 510(k) clearance?
SKOUT system received FDA 510(k) clearance on 2025-05-09, under 510(k) number K251126.
Who is the listed applicant for SKOUT system?
The FDA 510(k) record lists Iterative Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SKOUT system?
The FDA product code for SKOUT system is QNP.
相關臨床試驗
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其他以 Iterative Health 為申請人之記錄
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。
相關器械（代碼：QNP）
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。
K260133CADDIEOdin Medical LimitedK260567EW10-EC02內視鏡輔助程序Fujifilm CorporationK252853CAD - 下消化道 (EC07-01)Xiamen Inno Medical Technology Co., Ltd.K261369GI Geniux™ 模組 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT系統Iterative Health
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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