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FDA 510(k)

miPlatform医学影像套件v3.0（miPlatform v3.0），miPlatform ZFP查看器

K号: K171977 · 2018-08-02

申请人Hinacom Software and Technology, Ltd.
决定日期2018-08-02
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Hinacom Software and Technology, Ltd.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K171977. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Hinacom Software and Technology, Ltd.. The 510(k) number is K171977.

When did miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer receive FDA 510(k) clearance?

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer received FDA 510(k) clearance on 2018-08-02, under 510(k) number K171977.

Who is the listed applicant for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

The FDA 510(k) record lists Hinacom Software and Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer?

The FDA product code for miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer is LLZ.

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

相关器械（代码：LLZ）

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。

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio分析Replasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDS 请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方来源

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