qER-CTA（v1.0）
K号: K251610 · 2025-09-08
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器械摘要
qER-CTA (v1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K251610. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the qER-CTA (v1.0)?
qER-CTA (v1.0) is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Qure.Ai Technologies. The 510(k) number is K251610.
When did qER-CTA (v1.0) receive FDA 510(k) clearance?
qER-CTA (v1.0) received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251610.
Who is the listed applicant for qER-CTA (v1.0)?
The FDA 510(k) record lists Qure.Ai Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for qER-CTA (v1.0)?
The FDA product code for qER-CTA (v1.0) is QAS.
列明Qure.Ai Technologies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：QAS）
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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