Synapse 3D 灌注分析
K号: K162287 · 2017-04-06
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器械摘要
Synapse 3D Perfusion Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162287. 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 Synapse 3D Perfusion Analysis?
Synapse 3D Perfusion Analysis is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162287.
When did Synapse 3D Perfusion Analysis receive FDA 510(k) clearance?
Synapse 3D Perfusion Analysis received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162287.
Who is the listed applicant for Synapse 3D Perfusion Analysis?
The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Synapse 3D Perfusion Analysis?
The FDA product code for Synapse 3D Perfusion Analysis is LLZ.
相关临床试验
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列明Fujifilm Medical Systems U.S.A, Inc.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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