FDA 510(k)

Better Diagnostics 龋齿辅助（BDCA）版本1.0

K号: K241725 · 2025-03-11

决定日期2025-03-11

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

Better Diagnostics Caries Assist (BDCA) Version 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Better Diagnostics AI Corp.. It received FDA 510(k) clearance on 2025-03-11 under 510(k) number K241725. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Better Diagnostics Caries Assist (BDCA) Version 1.0?

Better Diagnostics Caries Assist (BDCA) Version 1.0 is a medical device that received FDA 510(k) clearance on 2025-03-11. The listed applicant is Better Diagnostics AI Corp.. The 510(k) number is K241725.

When did Better Diagnostics Caries Assist (BDCA) Version 1.0 receive FDA 510(k) clearance?

Better Diagnostics Caries Assist (BDCA) Version 1.0 received FDA 510(k) clearance on 2025-03-11, under 510(k) number K241725.

Who is the listed applicant for Better Diagnostics Caries Assist (BDCA) Version 1.0?

FDA 510(k)记录中列出Better Diagnostics AI Corp.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 Better Diagnostics Caries Assist (BDCA) Version 1.0?

The FDA product code for Better Diagnostics Caries Assist (BDCA) Version 1.0 is MYN.

列明Better Diagnostics AI Corp.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。

K260851更好的诊断牙科助手（BDDA）版本 1.0

官方来源

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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。