FDA 510(k)

更好的診斷蛀牙輔助設備 (BDCA) 版本 1.0

K 號：K241725 · 2025-03-11

決定日期2025-03-11

產品代碼MYN

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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) 記錄將Better Diagnostics AI Corp. 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Better Diagnostics AI Corp. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260851更好的診斷牙科輔助設備 (BDDA) 版本 1.0

相關器械（代碼：MYN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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