FDA 510(k)

MediAI-BA

K 號：K250914 · 2025-12-18

決定日期2025-12-18

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

MediAI-BA is the device name listed in this FDA 510(k) record. The listed applicant is Crescom Co., Ltd.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K250914. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MediAI-BA?

MediAI-BA is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Crescom Co., Ltd.. The 510(k) number is K250914.

When did MediAI-BA receive FDA 510(k) clearance?

MediAI-BA received FDA 510(k) clearance on 2025-12-18, under 510(k) number K250914.

Who is the listed applicant for MediAI-BA?

The FDA 510(k) record lists Crescom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MediAI-BA?

The FDA product code for MediAI-BA is QIH.

其他以 Crescom Co., Ltd. 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。

K253172MediAI-OA

相關器械（代碼：QIH）

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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。