免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

PENTAX醫療影片處理器EPK-i5500c，PENTAX醫療影片上消化道內視鏡EG29-i10c，PENTAX醫療影片大腸內視鏡EC34-i10cL，PENTAX醫療影片大腸內視鏡EC38-i10cL

K 號：K190805 · 2019-12-20

申請人Pentax of America, Inc.
決定日期2019-12-20
產品代碼PEA
諮詢委員會GU
決定相當於

器材摘要

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190805. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Pentax of America, Inc.. The 510(k) number is K190805.

When did PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL receive FDA 510(k) clearance?

PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190805.

Who is the listed applicant for PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL?

The FDA product code for PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL is PEA.

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 Pentax of America, Inc. 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。

K251256PENTAX醫療內視鏡上消化道內視鏡（EG系列）（EG系列）；PENTAX醫療內視鏡結腸內視鏡（EC系列）（EC系列）K251127PENTAX醫療影片處理器（EPK-i8020c）K242110PENTAX醫療內視鏡視頻結腸鏡（EC38-i20cWL）K241213PENTAX醫療內視鏡上消化道內視鏡（EG27-i20c）；PENTAX醫療內視鏡結腸內視鏡（EC34-i20cL）K233942PENTAX醫療內視鏡攝影十二指腸內視鏡（ED34-i10T2s）；PENTAX醫療內視鏡處理器（EPK-i8020c）；PENTAX醫療一次性、无菌遠端蓋子帶提升器（OE-A63）；氣/水供給閥（OF-B194）K240457C2 冷氣球消融系統（C2 冷氣球消融系統）

查看所有 39 項裝置 →

相關器械（代碼：PEA）

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。

K251127PENTAX醫療影片處理器（EPK-i8020c）Pentax of America, Inc.K231249PENTAX醫療影片處理器EPK-i8020c，PENTAX醫療影片上消化道內視鏡EG29-i20c，PENTAX醫療影片大腸內視鏡EC38-i20cLPentax of America, Inc.K191282PENTAX醫療EPK-i7010及PENTAX EPK-i5010內視鏡處理器，屬於GI系列Pentax of America, Inc.K173679PENTAX醫療EPK-i7010影片處理器，配EB系列鏡頭Pentax of America, Inc.K160275融合內視鏡系統搭配FuseBox處理器Endochoice, Inc.

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。

↑