NaviCam 小腸顯微鏡內視系統
K 號：K221590 · 2022-12-02
廣告
器材摘要
NaviCam Small Bowel Capsule Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Ankon Technologies Co., Ltd.. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221590. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NaviCam Small Bowel Capsule Endoscopy System?
NaviCam Small Bowel Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Ankon Technologies Co., Ltd.. The 510(k) number is K221590.
When did NaviCam Small Bowel Capsule Endoscopy System receive FDA 510(k) clearance?
NaviCam Small Bowel Capsule Endoscopy System received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221590.
Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System?
The FDA 510(k) record lists Ankon Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NaviCam Small Bowel Capsule Endoscopy System?
The FDA product code for NaviCam Small Bowel Capsule Endoscopy System is NEZ.
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。
相關器械（代碼：NEZ）
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。
K252617MiroCam® 胶囊內視鏡系統Intromedic Co., Ltd.K252480CE交付（DLV）CapsoVision, Inc.K242643CapsoCam Plus (SV-3) 胶囊內視鏡系統CapsoVision, Inc.K240276PillCam™ 天才 SB 系統搭配 PillCam 軟體 v9.7 及 PillCam雲端閱讀軟體Given Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam 小腸顱內鏡系統，配備 NaviCam SB 顱內鏡及 NaviCam 緊繫帶Anx Robotica CorporationK230991PillCam SB 3 胶囊內視鏡系統，PillCam 軟體 9.0EGiven Imaging Ltd. (Medtronic)
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。
廣告