MR 扩散灌注不匹配V1.0
K号: K223502 · 2023-01-13
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器械摘要
MR Diffusion Perfusion Mismatch V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223502. 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 MR Diffusion Perfusion Mismatch V1.0?
MR Diffusion Perfusion Mismatch V1.0 is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Olea Medical. The 510(k) number is K223502.
When did MR Diffusion Perfusion Mismatch V1.0 receive FDA 510(k) clearance?
MR Diffusion Perfusion Mismatch V1.0 received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223502.
Who is the listed applicant for MR Diffusion Perfusion Mismatch V1.0?
The FDA 510(k) record lists Olea Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MR Diffusion Perfusion Mismatch V1.0?
The FDA product code for MR Diffusion Perfusion Mismatch V1.0 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。
列明Olea Medical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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