FDA 510(k)

PowerLook 體積評估軟體

K 號：K180125 · 2018-04-05

決定日期2018-04-05

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

PowerLook Density Assessment Software is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180125. 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 PowerLook Density Assessment Software?

PowerLook Density Assessment Software is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Icad, Inc.. The 510(k) number is K180125.

When did PowerLook Density Assessment Software receive FDA 510(k) clearance?

PowerLook Density Assessment Software received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180125.

Who is the listed applicant for PowerLook Density Assessment Software?

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

What is the FDA product code for PowerLook Density Assessment Software?

The FDA product code for PowerLook Density Assessment Software is LLZ.

其他以 Icad, 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。

K240417ProFound Detection (V4.0)K211506PowerLook 體積評估 V4.0 K203822ProFound AI 軟體 V3.0 K191994ProFound AI 軟體 V2.1 K182373PowerLook 螢光檢測 V2 軟體 K153570Axxent 電子近端放射治療系統 110 XP 1200 型號

查看所有 7 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。