uDR 瑶光 CX
K号: K251167 · 2025-09-19
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器械摘要
uDR Aurora CX is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K251167. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the uDR Aurora CX?
uDR Aurora CX is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K251167.
When did uDR Aurora CX receive FDA 510(k) clearance?
uDR Aurora CX received FDA 510(k) clearance on 2025-09-19, under 510(k) number K251167.
Who is the listed applicant for uDR Aurora CX?
FDA 510(k)记录将上海联影医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for uDR Aurora CX?
The FDA product code for uDR Aurora CX is KPR.
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Shanghai United Imaging Healthcare Co., Ltd.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。
K253726uAngio AVIVA CXK261427uMI Panvivo（uMI Panvivo M）K260113uMR AstraK253077uOmnispace.MRK260524uMI Panvivo（uMI Panvivo LS）；uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）K253564uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）
相关器械（代码：KPR）
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。
K260227EXSYS DEXi（EXSYS DEXi-S40S）；EXSYS DEXi（EXSYS DEXi-S40P）；EXSYS DEXi（EXSYS DEXi-S40T）；EXSYS DEXi（EXSYS DEXi-S50H）DRTECH CorporationK260488MULTIX Impact；MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器Carestream Health
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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