FDA 510(k)

Optima XR240amx, AutoGrid

K-Number: K173602 · 2018-01-12

Decision Date2018-01-12

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Optima XR240amx, AutoGrid is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2018-01-12 under approval number K173602. 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 Optima XR240amx, AutoGrid?

Optima XR240amx, AutoGrid is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K173602.

When was Optima XR240amx, AutoGrid approved by the FDA?

Optima XR240amx, AutoGrid received FDA 510(k) clearance on 2018-01-12, under approval number K173602.

What company makes Optima XR240amx, AutoGrid?

Optima XR240amx, AutoGrid is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for Optima XR240amx, AutoGrid?

The FDA product code for Optima XR240amx, AutoGrid is IZL.

Other Devices by Ge Medical Systems, LLC

K163213Revolution CT K162403HyperBand K162990Optima XR240amx K161397MAGiC K161574Discovery MI K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

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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.