3DXR
K号: K243446 · 2025-02-25
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器械摘要
3DXR is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2025-02-25 under 510(k) number K243446. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 3DXR?
3DXR is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is GE Medical Systems SCS. The 510(k) number is K243446.
When did 3DXR receive FDA 510(k) clearance?
3DXR received FDA 510(k) clearance on 2025-02-25, under 510(k) number K243446.
Who is the listed applicant for 3DXR?
FDA 510(k)记录列出了GE医疗系统SCS为申请人。这本身并不能确立该设备制造商。
What is the FDA product code for 3DXR?
The FDA product code for 3DXR is OWB.
列明GE Medical Systems SCS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：OWB）
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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