FDA 510(k)

Europa（备选：AiRTouch）便携式X射线系统

K号: K244049 · 2025-05-28

决定日期2025-05-28

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Livermoretech, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193535EZER，便携式 X 射线系统 K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System K193644E-COM DR-2000 DR K190935EZER，便携式 X 射线系统 K180663LaVid FMTS 诊断 X 射线系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。