Nucleus 图像管理系统
K号: K171130 · 2017-05-04
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器械摘要
Nucleus Image Management System is the device name listed in this FDA 510(k) record. The listed applicant is Nucleushealth, LLC. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K171130. 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 Nucleus Image Management System?
Nucleus Image Management System is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Nucleushealth, LLC. The 510(k) number is K171130.
When did Nucleus Image Management System receive FDA 510(k) clearance?
Nucleus Image Management System received FDA 510(k) clearance on 2017-05-04, under 510(k) number K171130.
Who is the listed applicant for Nucleus Image Management System?
The FDA 510(k) record lists Nucleushealth, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nucleus Image Management System?
The FDA product code for Nucleus Image Management System is LLZ.
相关临床试验
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列明Nucleushealth, LLC为申报人的其他记录
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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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