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FDA 510(k)

VISERA ELITE III 選擇式影像系統中心 OLYMPUS OTV-S700；VISERA ELITE III LED光源 OLYMPUS CLL-S700；4K鏡頭頭 OLYMPUS CH-S700-XZ-EA

K 號：K242067 · 2025-04-02

申請人Olympus Corporations of the Americas
決定日期2025-04-02
產品代碼FET
諮詢委員會GU
決定相當於

器材摘要

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corporations of the Americas. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242067. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA?

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Olympus Corporations of the Americas. The 510(k) number is K242067.

When did VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA receive FDA 510(k) clearance?

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242067.

Who is the listed applicant for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA?

The FDA 510(k) record lists Olympus Corporations of the Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA?

The FDA product code for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is FET.

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

相關器械（代碼：FET）

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。

K2620794K攝影鏡頭 OLYMPUS CH-S700-08-LB 医療設備規範文本Olympus Medical Systems Corp.K261880富士通電子處理器EP-8000；氣球控制器PB-30；內視鏡輔助程序EW10-VM01Fujifilm CorporationK261260HD攝影鏡頭 OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee影片處理單元（PV-003）Proverum LimitedK250462UL UHD-Clear View 4K攝影系統（UL-3Chip 4K）Univlabs Technologies Private LimitedK250204內視鏡攝影系統Shenzhen Sophway Technology Co., Ltd.

官方來源

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