FDA 510(k)

真計劃

K 號：K202212 · 2021-02-19

決定日期2021-02-19

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

TruPlan is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202212. 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 TruPlan?

TruPlan is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K202212.

When did TruPlan receive FDA 510(k) clearance?

TruPlan received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202212.

Who is the listed applicant for TruPlan?

The FDA 510(k) record lists Circle Cardiovascular Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruPlan?

The FDA product code for TruPlan is LLZ.

其他以 Circle Cardiovascular Imaging, 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。

K251027cvi42 冠狹膽軟體應用程序 K250221中風感測 ASPECTS 軟體應用程序 K242781cvi42 軟體應用程序 K222593TruPlan 電腦斷層掃描（CT）影像軟體 K213998cvi42 自動影像軟體應用程序

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。