FDA 510(k)

ME-APDS™；MAGENTIQ-COLO™

K 號：K223473 · 2023-07-25

決定日期2023-07-25

產品代碼QNP

諮詢委員會GU

決定相當於

器材摘要

ME-APDS™; MAGENTIQ-COLO™ is the device name listed in this FDA 510(k) record. The listed applicant is Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K223473. 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 ME-APDS™; MAGENTIQ-COLO™?

ME-APDS™; MAGENTIQ-COLO™ is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Magentiq Eye, Ltd.. The 510(k) number is K223473.

When did ME-APDS™; MAGENTIQ-COLO™ receive FDA 510(k) clearance?

ME-APDS™; MAGENTIQ-COLO™ received FDA 510(k) clearance on 2023-07-25, under 510(k) number K223473.

Who is the listed applicant for ME-APDS™; MAGENTIQ-COLO™?

The FDA 510(k) record lists Magentiq Eye, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ME-APDS™; MAGENTIQ-COLO™?

The FDA product code for ME-APDS™; MAGENTIQ-COLO™ is QNP.

其他以 Magentiq Eye, 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。

K260724MAGENTIQ-COLO (ME-APDS)K252178MAGENTIQ-COLO (ME-APDS)K244023MAGENTIQ-COLO (ME-APDS)

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 Limited K260567EW10-EC02內視鏡輔助程序Fujifilm Corporation K252853CAD - 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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