FDA 510(k)

Clarius 前列腺 AI

K 號：K243853 · 2025-04-16

決定日期2025-04-16

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Clarius Prostate AI is the device name listed in this FDA 510(k) record. The listed applicant is Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K243853. 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 Clarius Prostate AI?

Clarius Prostate AI is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K243853.

When did Clarius Prostate AI receive FDA 510(k) clearance?

Clarius Prostate AI received FDA 510(k) clearance on 2025-04-16, under 510(k) number K243853.

Who is the listed applicant for Clarius Prostate AI?

The FDA 510(k) record lists Clarius Mobile Health Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarius Prostate AI?

The FDA product code for Clarius Prostate AI is QIH.

其他以 Clarius Mobile Health 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。

K253593Clarius 心輸出量 AI K250226Clarius Median Nerve AI K233955Clarius 智能化醫療設備規範文本 K232257Clarius 膀胱 AI K232704Clarius 超聲波掃描儀 K222406Clarius AI

查看所有 12 項裝置 →

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。