FDA 510(k)

Denti.AI 自動編圖器

K 號：K222054 · 2022-11-22

決定日期2022-11-22

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Denti.AI Auto-Chart is the device name listed in this FDA 510(k) record. The listed applicant is Denti.Ai Technology, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222054. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Denti.AI Auto-Chart?

Denti.AI Auto-Chart is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Denti.Ai Technology, Inc.. The 510(k) number is K222054.

When did Denti.AI Auto-Chart receive FDA 510(k) clearance?

Denti.AI Auto-Chart received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222054.

Who is the listed applicant for Denti.AI Auto-Chart?

The FDA 510(k) record lists Denti.Ai Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denti.AI Auto-Chart?

The FDA product code for Denti.AI Auto-Chart is LLZ.

其他以 Denti.Ai Technology, Inc. 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。

K230144Denti.AI偵測

相關器械（代碼：LLZ）

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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, 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。