xR 体外诊断设备
K号: K241868 · 2025-09-19
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决定日期2025-09-19
产品代码PZM
咨询委员会PA
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。
决定实质等同
器械摘要
xR IVD is the device name listed in this FDA 510(k) record. The listed applicant is Tempus AI, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K241868. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the xR IVD?
xR IVD is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Tempus AI, Inc.. The 510(k) number is K241868.
When did xR IVD receive FDA 510(k) clearance?
xR IVD received FDA 510(k) clearance on 2025-09-19, under 510(k) number K241868.
Who is the listed applicant for xR IVD?
FDA 510(k)记录中列出Tempus AI，Inc.为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for xR IVD?
The FDA product code for xR IVD is PZM.
列明Tempus AI, Inc.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：PZM）
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。
K260235CellDx-TissueDatar Cancer Genetics Private LimitedK250003GENESEEQPRIME NGS 肿瘤分析检测（FFPE）（GS6005）Geneseeq Technology, Inc.K210017ACTOnco, ACTOnco IVDAct GenomicsK202304NYU Langone Genome PACT (可行动癌症靶点的基因组分析)Nyu Langone Medical CenterK192063PGDx elio 组织完整Personal Genome DiagnosticsK190661Omics CoreNanthealth, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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