BIOGRAPH 一号
K号: K253023 · 2026-01-15
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器械摘要
BIOGRAPH One is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers AG. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K253023. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BIOGRAPH One?
BIOGRAPH One is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Siemens Healthineers AG. The 510(k) number is K253023.
When did BIOGRAPH One receive FDA 510(k) clearance?
BIOGRAPH One received FDA 510(k) clearance on 2026-01-15, under 510(k) number K253023.
Who is the listed applicant for BIOGRAPH One?
FDA 510(k)记录显示西门子医疗保健股份公司（Siemens Healthineers AG）为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for BIOGRAPH One?
The FDA product code for BIOGRAPH One is OUO.
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Siemens Healthineers AG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：OUO）
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。
K253963Cubresa 脑PETCubresa, Inc.K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA PET/MRGe Medical Systems, LLCK200213Biograph mMR带syngo MR E11P-AP01系统软件Siemens Medical Solutions USA, Inc.K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.
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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