FDA 510(k)

快速 MLS

K 號：K243378 · 2025-05-28

決定日期2025-05-28

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Rapid MLS is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K243378. 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 Rapid MLS?

Rapid MLS is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Ischemaview, Inc.. The 510(k) number is K243378.

When did Rapid MLS receive FDA 510(k) clearance?

Rapid MLS received FDA 510(k) clearance on 2025-05-28, under 510(k) number K243378.

Who is the listed applicant for Rapid MLS?

FDA 510(k) 記錄將 Ischemaview, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Rapid MLS?

The FDA product code for Rapid MLS is QIH.

其他以 Ischemaview, 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。

K261368快速平台（R6.7）K251987快速主动脉測量 K251533快速阻塞性腦積水，快速OH K252526快速DeltaFuse K243350快速神經3D K233582快速

查看所有 21 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。