AerFrame患者固定系统（AFPIS）
K号: K260792 · 2026-05-08
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器械摘要
AerFrame Patient Immobilization System (AFPIS) is the device name listed in this FDA 510(k) record. The listed applicant is Stabilix, LLC. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K260792. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AerFrame Patient Immobilization System (AFPIS)?
AerFrame Patient Immobilization System (AFPIS) is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Stabilix, LLC. The 510(k) number is K260792.
When did AerFrame Patient Immobilization System (AFPIS) receive FDA 510(k) clearance?
AerFrame Patient Immobilization System (AFPIS) received FDA 510(k) clearance on 2026-05-08, under 510(k) number K260792.
Who is the listed applicant for AerFrame Patient Immobilization System (AFPIS)?
FDA 510(k)记录中列出Stabilix, LLC为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for AerFrame Patient Immobilization System (AFPIS)?
The FDA product code for AerFrame Patient Immobilization System (AFPIS) is IYE.
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Stabilix, 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：IYE）
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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