syngo.CT 肺部计算机辅助诊断系统（版本 VD30）
K号: K231157 · 2023-07-19
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器械摘要
syngo.CT Lung CAD (Version VD30) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231157. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the syngo.CT Lung CAD (Version VD30)?
syngo.CT Lung CAD (Version VD30) is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K231157.
When did syngo.CT Lung CAD (Version VD30) receive FDA 510(k) clearance?
syngo.CT Lung CAD (Version VD30) received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231157.
Who is the listed applicant for syngo.CT Lung CAD (Version VD30)?
The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for syngo.CT Lung CAD (Version VD30)?
The FDA product code for syngo.CT Lung CAD (Version VD30) is OEB.
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 Healthcare GmbH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。
K253264我的消融指南（VC10A）K253689syngo Dynamics (VA41F)K252548AI-Rad Companion器官实时放疗K253057AI-Rad Companion脑部MRIK252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion前列腺MRI
相关器械（代码：OEB）
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。
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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