Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Europa (Alternative: AiRTouch) portable X-ray system

K-Number: K244049 · 2025-05-28

ApplicantLivermoretech, Inc.
Decision Date2025-05-28
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Livermoretech, Inc.. The 510(k) number is K244049.

When was Europa (Alternative: AiRTouch) portable X-ray system approved by the FDA?

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

What company makes Europa (Alternative: AiRTouch) portable X-ray system?

Europa (Alternative: AiRTouch) portable X-ray system is manufactured by Livermoretech, Inc..

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.

Related Clinical Trials

NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_RECRUITING NCT05673408 NIBP Validation Study RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07291765 Blood Flow Restriction Training in Acute Geriatric Rehabilitation RECRUITING

Other Devices by Livermoretech, Inc.

K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEM K190935EZER, Portable X-ray System K193535EZER, Portable X-ray System K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System K193644E-COM DR-2000 DR

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑