FDA 510(k)

快速

K 號：K233582 · 2024-04-22

決定日期2024-04-22

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Rapid is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2024-04-22 under 510(k) number K233582. 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 Rapid?

Rapid is a medical device that received FDA 510(k) clearance on 2024-04-22. The listed applicant is Ischemaview, Inc.. The 510(k) number is K233582.

When did Rapid receive FDA 510(k) clearance?

Rapid received FDA 510(k) clearance on 2024-04-22, under 510(k) number K233582.

Who is the listed applicant for Rapid?

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?

The FDA product code for Rapid is LLZ.

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 K243378快速 MLS K243350快速神經3D

查看所有 21 項裝置 →

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。

快速