FDA 510(k)

US2.v1

K 號：K210791 · 2021-07-27

決定日期2021-07-27

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Us2.v1 is the device name listed in this FDA 510(k) record. The listed applicant is Eko.Ai Pte Ltd. D/B/A Us2.Ai. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K210791. 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 Us2.v1?

Us2.v1 is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Eko.Ai Pte Ltd. D/B/A Us2.Ai. The 510(k) number is K210791.

When did Us2.v1 receive FDA 510(k) clearance?

Us2.v1 received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210791.

Who is the listed applicant for Us2.v1?

The FDA 510(k) record lists Eko.Ai Pte Ltd. D/B/A Us2.Ai as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Us2.v1?

The FDA product code for Us2.v1 is QIH.

其他以 Eko.Ai Pte Ltd. D/B/A Us2.Ai 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。

K250151US2.ca K233676Us2.v2

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。