VinDr-乳腺设备
K号: K233108 · 2024-05-23
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器械摘要
VinDr-Mammo is the device name listed in this FDA 510(k) record. The listed applicant is Vinbigdata Joint Stock Company. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233108. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VinDr-Mammo?
VinDr-Mammo is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Vinbigdata Joint Stock Company. The 510(k) number is K233108.
When did VinDr-Mammo receive FDA 510(k) clearance?
VinDr-Mammo received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233108.
Who is the listed applicant for VinDr-Mammo?
The FDA 510(k) record lists Vinbigdata Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VinDr-Mammo?
The FDA product code for VinDr-Mammo is QFM.
相关临床试验
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相关器械（代码：QFM）
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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