GI 神奇
K 號：K211951 · 2021-07-23
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器材摘要
GI Genius is the device name listed in this FDA 510(k) record. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K211951. 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 GI Genius?
GI Genius is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K211951.
When did GI Genius receive FDA 510(k) clearance?
GI Genius received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211951.
Who is the listed applicant for GI Genius?
The FDA 510(k) record lists Cosmo Artificial Intelligence - Ai, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GI Genius?
The FDA product code for GI Genius is QNP.
相關臨床試驗
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其他以 Cosmo Artificial Intelligence - Ai, Ltd. 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。
K261369GI Geniux™ 模組 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)K241887GI Genius™ 模組 100 (GGM100.US)；GI Genius™ 模組 200 (GGM200.US)；ColonPRO™ 4.0 (CPRO40.US)；GI Genius™ 模組 300 (GGM300-US)；ColonPRO™ 4.0 (CPRO40S-US)K233964GI Genius™ 模組 100 (GGM100.US)；GI Genius™ 模組 200 (GGM200.US)；ColonPRO™ 4.0 (CPRO40.US)K231143GI Geniux 系統 100 及 GI Geniux 系統 200
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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