Enhanced Boundary for PCCT
K号: K253560 · 2026-06-24
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器械摘要
Enhanced Boundary for PCCT 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 2026-06-24 under 510(k) number K253560. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Enhanced Boundary for PCCT?
Enhanced Boundary for PCCT is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253560.
When did Enhanced Boundary for PCCT receive FDA 510(k) clearance?
Enhanced Boundary for PCCT received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253560.
Who is the listed applicant for Enhanced Boundary for PCCT?
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 Enhanced Boundary for PCCT?
The FDA product code for Enhanced Boundary for PCCT is JAK.
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：JAK）
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。
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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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