CAAS MR 4D 流
K号: K162376 · 2016-12-08
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器械摘要
CAAS MR 4D Flow is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162376. 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 CAAS MR 4D Flow?
CAAS MR 4D Flow is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K162376.
When did CAAS MR 4D Flow receive FDA 510(k) clearance?
CAAS MR 4D Flow received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162376.
Who is the listed applicant for CAAS MR 4D Flow?
The FDA 510(k) record lists Pie Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CAAS MR 4D Flow?
The FDA product code for CAAS MR 4D Flow is LLZ.
列明Pie Medical Imaging BV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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