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FDA 510(k)

GI 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)

K 號：K241887 · 2024-07-25

申請人Cosmo Artificial Intelligence - Ai, Ltd.
決定日期2024-07-25
產品代碼QNP
諮詢委員會GU
決定相當於

器材摘要

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) 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 2024-07-25 under 510(k) number K241887. 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™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) is a medical device that received FDA 510(k) clearance on 2024-07-25. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K241887.

When did GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) receive FDA 510(k) clearance?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) received FDA 510(k) clearance on 2024-07-25, under 510(k) number K241887.

Who is the listed applicant for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)?

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™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)?

The FDA product code for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) is QNP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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)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 200K211951GI 神奇

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

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