SIGNA PET/MR
K号: K213709 · 2022-01-20
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器械摘要
SIGNA PET/MR is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K213709. 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 SIGNA PET/MR?
SIGNA PET/MR is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K213709.
When did SIGNA PET/MR receive FDA 510(k) clearance?
SIGNA PET/MR received FDA 510(k) clearance on 2022-01-20, under 510(k) number K213709.
Who is the listed applicant for SIGNA PET/MR?
The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SIGNA PET/MR?
The FDA product code for SIGNA PET/MR 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Ge Medical Systems, LLC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.K253023BIOGRAPH 一号Siemens Healthineers AGK234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K200213Biograph 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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