FDA 510(k)

LVivo IQS

K 號：K240769 · 2024-05-24

決定日期2024-05-24

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

LVivo IQS is the device name listed in this FDA 510(k) record. The listed applicant is Dia Imaging Analysis, Ltd.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240769. 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 LVivo IQS?

LVivo IQS is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Dia Imaging Analysis, Ltd.. The 510(k) number is K240769.

When did LVivo IQS receive FDA 510(k) clearance?

LVivo IQS received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240769.

Who is the listed applicant for LVivo IQS?

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

What is the FDA product code for LVivo IQS?

The FDA product code for LVivo IQS is QIH.

其他以 Dia Imaging Analysis, 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。

K243862LVivo 軟體應用程序 K243331LVivo 無縫 K243235LVivo 軟體應用程序 K240553LVivo 軟體應用程序 K222970LVivo IQS K212466LVivo 無縫

查看所有 10 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。