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FDA 510(k)

EZER, Portable X-ray System

K-Number: K193535 · 2020-05-07

ApplicantLivermoretech, Inc.
Decision Date2020-05-07
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EZER, Portable X-ray System is a medical device manufactured by Livermoretech, Inc.. It received FDA 510(k) clearance on 2020-05-07 under approval number K193535. 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 EZER, Portable X-ray System?

EZER, Portable X-ray System is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Livermoretech, Inc.. The 510(k) number is K193535.

When was EZER, Portable X-ray System approved by the FDA?

EZER, Portable X-ray System received FDA 510(k) clearance on 2020-05-07, under approval number K193535.

What company makes EZER, Portable X-ray System?

EZER, Portable X-ray System is manufactured by Livermoretech, Inc..

What is the FDA product code for EZER, Portable X-ray System?

The FDA product code for EZER, Portable X-ray System is IZL.

Related Clinical Trials

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Other Devices by Livermoretech, Inc.

K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEM K190935EZER, Portable X-ray System K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System K193644E-COM DR-2000 DR K244049Europa (Alternative: AiRTouch) portable X-ray system

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

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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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