FDA 510(k)

医療内視鏡画像処理システム

K番号: K210270 · 2021-10-01

申請者Jiangsu Jiyuan Medical Technology Co., Ltd.

決定日2021-10-01

製品コードHIH

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてJiangsu Jiyuan Medical Technology Co., Ltd.を記載するその他の記録

K252793ARMI® 内視鏡ビデオ画像処理装置（JY-MIP-3000）；ARMI® 一回使用式子宮鏡（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）

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