FDA 510(k)

影像套件

K 號：K251168 · 2025-09-04

決定日期2025-09-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Image Suite is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251168. 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 Image Suite?

Image Suite is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Carestream Health, Inc.. The 510(k) number is K251168.

When did Image Suite receive FDA 510(k) clearance?

Image Suite received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251168.

Who is the listed applicant for Image Suite?

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

What is the FDA product code for Image Suite?

The FDA product code for Image Suite is LLZ.

其他以 Carestream Health, 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。

K241505DRX-革命型移動X光系統 K233381DRX-Evolution Plus 系統 K223842DRX - 磁羅盤 K213307Eclipse II 智能噪音消除器 K202441Eclipse II 智能噪音消除器 K201373DRX-指南針

查看所有 23 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。