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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 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.

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. 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.

Other records listing Livermoretech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193535EZER, Portable X-ray SystemK200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemK193644E-COM DR-2000 DRK190935EZER, Portable X-ray SystemK180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEM

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Official Source

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

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