FDA 510(k)

歐羅巴（備選名稱：AiRTouch）可攜帶式X光系統

K 號：K244049 · 2025-05-28

決定日期2025-05-28

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

Europa (Alternative: AiRTouch) portable X-ray system is the device name listed in this FDA 510(k) record. The listed applicant is Livermoretech, Inc.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K244049. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Europa (Alternative: AiRTouch) portable X-ray system?

Europa (Alternative: AiRTouch) portable X-ray system is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Livermoretech, Inc.. The 510(k) number is K244049.

When did Europa (Alternative: AiRTouch) portable X-ray system receive FDA 510(k) clearance?

Europa (Alternative: AiRTouch) portable X-ray system received FDA 510(k) clearance on 2025-05-28, under 510(k) number K244049.

Who is the listed applicant for Europa (Alternative: AiRTouch) portable X-ray system?

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

What is the FDA product code for Europa (Alternative: AiRTouch) portable X-ray system?

The FDA product code for Europa (Alternative: AiRTouch) portable X-ray system is IZL.

其他以 Livermoretech, 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。

K193535EZER，可攜式X光系統 K200022FLUSION-9001，顯影C臂移動X光系統 K193644E-COM DR-2000 DR 医療設備規範文本 E-COM DR-2000 DR 医療設備，FDA 認證，510(k) 認可，PMA 認證，NCT 研究編號，PMID 文獻編號，識別碼及網址。K190935EZER，可攜式X光系統 K180663LaVid FMTS 診斷 X 光系統

相關器械（代碼：IZL）

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。

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058攜帶式DR影像系統Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO移動X光系統（型號：RAYMO）DRGEM Corporation K253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream Health K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

官方來源

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