BBX-PET 扫描仪
K号: K210450 · 2021-03-17
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器械摘要
BBX-PET Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Prescient Imaging, LLC. It received FDA 510(k) clearance on 2021-03-17 under 510(k) number K210450. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BBX-PET Scanner?
BBX-PET Scanner is a medical device that received FDA 510(k) clearance on 2021-03-17. The listed applicant is Prescient Imaging, LLC. The 510(k) number is K210450.
When did BBX-PET Scanner receive FDA 510(k) clearance?
BBX-PET Scanner received FDA 510(k) clearance on 2021-03-17, under 510(k) number K210450.
Who is the listed applicant for BBX-PET Scanner?
The FDA 510(k) record lists Prescient Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BBX-PET Scanner?
The FDA product code for BBX-PET Scanner is KPS.
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。
相关器械（代码：KPS）
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。
K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo（uMI Panvivo M）Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 系列Siemens Medical Solutions USA, Inc.K260524uMI Panvivo（uMI Panvivo LS）；uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300系列数字SPECT/CT系统（VERITON CT 316/364）；VERITON CT 400系列数字SPECT/CT系统（VERITON CT 416/464）Spectrum Dynamics Medical, 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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