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FDA 510(k)

共聚焦微探针成像系统（BrightP980）；共聚焦微探针成像系统（BrightP960）；共聚焦微探针成像系统（BrightP880）；共聚焦微探针成像系统（BrightP860）；共聚焦微探针成像系统（BrightP780）；共聚焦微探针成像系统（BrightP750）；共聚焦微探针成像系统（BrightP680）；共聚焦微探针成像系统（BrightP660）；共聚焦微探针成像系统（BrightP600）；共聚焦微探针成像系统（BrightP580）；

K号: K243711 · 2025-07-24

申请人Wuxi Hisky Medical Technologies Co., Ltd.
决定日期2025-07-24
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

Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Hisky Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K243711. 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 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);?

Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Wuxi Hisky Medical Technologies Co., Ltd.. The 510(k) number is K243711.

When did Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); receive FDA 510(k) clearance?

Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); received FDA 510(k) clearance on 2025-07-24, under 510(k) number K243711.

Who is the listed applicant for Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);?

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

What is the FDA product code for Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);?

The FDA product code for Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); 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。

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列明Wuxi Hisky Medical Technologies Co., Ltd.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。

K250026剪切波定量超声诊断系统（FH9000/FH7000/FH6000/FH5000/FH3000/FH1000）K243880剪切波定量超声诊断系统（Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100）K200136剪切波定量超声诊断系统K173595剪切波定量超声诊断系统

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.K260108L12 LED 光源带AIMStryker Endoscopy

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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