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FDA 510(k)

VISERA ELITE III 视频系统中心 奥林巴斯 OTV-S700（OTV-S700）；VISERA ELITE III 光源 奥林巴斯 CLL-S700（CLL-S700）；4K 摄像头 奥林巴斯 CH-S700-XZ-EA（CH-S700-XZ-EA）

K号: K251336 · 2025-11-12

申请人Olympus Medical Systems Corp.
决定日期2025-11-12
产品代码OWN
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K251336. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)?

VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K251336.

When did VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) receive FDA 510(k) clearance?

VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) received FDA 510(k) clearance on 2025-11-12, under 510(k) number K251336.

Who is the listed applicant for VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)?

FDA 510(k)记录中列出Olympus Medical Systems Corp.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)?

The FDA product code for VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) is OWN.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Olympus Medical Systems Corp.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K2620794K摄像头头 OLYMPUS CH-S700-08-LBK254056THUNDERBEAT 5 mm, 45 cm, 前驱动握把类型S (TB-0545FCS)；THUNDERBEAT 5 mm, 35 cm, 前驱动握把类型S (TB-0535FCS)；THUNDERBEAT 5 mm, 20 cm, 前驱动握把类型S (TB-0520FCS)K260580单次使用可重装夹子应用器（HX-810LR，HX-810UR）；夹子（HX-610-090，HX-610-135）；长夹子（HX-610-090L，HX-610-135L）；短夹子（HX-610-090S，HX-610-135S）；超短夹子（HX-610-135XS）K252341EVIS EXERA III 喉镜 (OLYMPUS BF-Q190); EVIS EXERA III 喉镜 (OLYMPUS BF-H190); EVIS EXERA III 喉镜 (OLYMPUS BF-1TH190)K251807一次性电外科止血镊 FD-410LR, FD-411UR, FD-412LRK253646一次性远端盖 MAJ-2315 (MAJ-2315)

查看所有 80 个设备 →

相关器械（代码：OWN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KGK254180PerfusiX-影像LIMIS Development B.V.K242163SmartSurgN 视觉化系统SmartsurgN, Inc.K254242KARL STORZ ICG成像系统带RUBINA®镜头Karl Storz SE & CO. KGK251852cCeLL - 在体内使用Drop-In Robo（CN100-2W2C488775，CN100-1W1C775，DR200）VPIX Medical, Inc.K253972IMAGE1 (TC400US)；X-to-4U 适配器 (TC040)Karl Storz SE & CO. KG

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