I4（集成智能成像信息）系统
K号: K160315 · 2016-02-19
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器械摘要
I4 (Integrated Intelligent Imaging Informatics) system is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K160315. 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 I4 (Integrated Intelligent Imaging Informatics) system?
I4 (Integrated Intelligent Imaging Informatics) system is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K160315.
When did I4 (Integrated Intelligent Imaging Informatics) system receive FDA 510(k) clearance?
I4 (Integrated Intelligent Imaging Informatics) system received FDA 510(k) clearance on 2016-02-19, under 510(k) number K160315.
Who is the listed applicant for I4 (Integrated Intelligent Imaging Informatics) system?
FDA 510(k)记录中列出Philips Medical Systems Nederland B.V.为申请人。这本身并不足以确定该设备的制造商。
What is the FDA product code for I4 (Integrated Intelligent Imaging Informatics) system?
The FDA product code for I4 (Integrated Intelligent Imaging Informatics) system is LLZ.
相关临床试验
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列明Philips Medical Systems Nederland B.V.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。
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。
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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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