FDA 510(k)

AMX Navigate

K-Number: K210982 · 2021-04-28

Decision Date2021-04-28

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AMX Navigate is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-04-28 under approval number K210982. 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 AMX Navigate?

AMX Navigate is a medical device that received FDA 510(k) clearance on 2021-04-28. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K210982.

When was AMX Navigate approved by the FDA?

AMX Navigate received FDA 510(k) clearance on 2021-04-28, under approval number K210982.

What company makes AMX Navigate?

AMX Navigate is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for AMX Navigate?

The FDA product code for AMX Navigate is IZL.

Other Devices by Ge Medical Systems, LLC

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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.