RadOncAI
K号: K253050 · 2026-06-18
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器械摘要
RadOncAI is the device name listed in this FDA 510(k) record. The listed applicant is Informai. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253050. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RadOncAI?
RadOncAI is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Informai. The 510(k) number is K253050.
When did RadOncAI receive FDA 510(k) clearance?
RadOncAI received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253050.
Who is the listed applicant for RadOncAI?
The FDA 510(k) record lists Informai as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RadOncAI?
The FDA product code for RadOncAI is MUJ.
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相关器械（代码：MUJ）
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
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