FDA 510(k)

醫用內視鏡影像處理系統

K 號：K210270 · 2021-10-01

申請人Jiangsu Jiyuan Medical Technology Co., Ltd.

決定日期2021-10-01

產品代碼HIH

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Medical Endoscope Image Processing System is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) number K210270. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medical Endoscope Image Processing System?

Medical Endoscope Image Processing System is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Jiangsu Jiyuan Medical Technology Co., Ltd.. The 510(k) number is K210270.

When did Medical Endoscope Image Processing System receive FDA 510(k) clearance?

Medical Endoscope Image Processing System received FDA 510(k) clearance on 2021-10-01, under 510(k) number K210270.

Who is the listed applicant for Medical Endoscope Image Processing System?

The FDA 510(k) record lists Jiangsu Jiyuan Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Endoscope Image Processing System?

The FDA product code for Medical Endoscope Image Processing System is HIH.

其他以 Jiangsu Jiyuan Medical Technology Co., 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。

K252793ARMI® 内窥镜视频图像处理器 (JY-MIP-3000); ARMI® 单次使用宫腔镜 (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

相關器械（代碼：HIH）

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。

K254252UNIDRIVE SIII 系統；HOPKINS 望遠鏡 0º (26205AMA) 作業套管 (26205CD) 塞子 (26205OC) 修鬆刀片 (26205SA) 修鬆刀片 (26205SB) 修鬆刀片 (091133-01/-10) 修鬆刀片 (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE選擇系統Karl Storz SE & CO. KG K254294單次使用數位宮頸鏡（GYUT-A 12.6- 0、GYUT-A12.6- 12、GYUT-A 12.6- 22、GYUT-A 12.6- 30、GYUT-A 14.4- 0、GYUT-A 14.4- 12、GYUT-A 14.4- 22、GYUT-A 14.4- 30、GYUT-B 15- 0、GYUT-B 15- 12、GYUT-B 15-22、GYUT-B 15- 30）Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5切除設備（5FR1PK）；HERizon RD5切除設備 - 5入包裝（5FR5PK）Axora Medical, Inc.K253020史特劳斯外科切除儀器American Medical Endoscopy, Inc.K254050手動組織移除設備Suzhou AcuVu Medical Technology Co., Ltd.

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。