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AMX Navigate Mobile X-Ray System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210982

by GE Medical Systems, LLC

Identifiers

510(k) Number
K210982 FDA 510(k)
FDA Product Code
IZL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1720 FDA 510(k)
Regulation Number
892.1720 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AMX Navigate is a Mobile X-Ray System, designed for portable radiographic imaging. It provides real-time fluoroscopy and digital radiography to support diagnostic and interventional procedures across various clinical settings, including emergency rooms, operating rooms, and radiology departments. Its mobile design enables flexible positioning for patients who cannot be easily moved to fixed imaging equipment.

This system is supplied as a reusable medical device, intended for use in radiology departments and clinical environments requiring mobile imaging solutions. It is not classified as MRI-safe or MRI-conditional, and its regulatory authorisations include FDA 510K clearance and EU MDR compliance. The device operates under Special 510(k) clearance with a classification of Class II, adhering to regulatory standards for X-ray imaging systems.

Frequently asked questions

Is the AMX Navigate designed for use in MRI environments, or does it pose any risks in those settings?

The AMX Navigate is explicitly not classified as MRI-safe or MRI-conditional, meaning it should not be used in MRI environments. Its design and materials are not compatible with MRI systems, which could pose risks to patients or interfere with imaging. Always verify the room’s equipment before use to avoid potential hazards.

How is the AMX Navigate supplied, and what does its reusable status mean for maintenance and cleaning?

The AMX Navigate is supplied as a reusable medical device, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This requires adherence to manufacturer guidelines for sterilization (if applicable) and routine servicing to ensure performance, safety, and compliance with infection control protocols. Reusability also implies the need for a dedicated maintenance program to extend the device’s lifespan.

What clinical settings is the AMX Navigate primarily intended for, and why is mobility a key feature?

The AMX Navigate is designed for portable radiographic imaging in settings where fixed equipment isn’t feasible, such as emergency rooms, operating rooms, and radiology departments. Its mobile design allows flexible positioning for patients who cannot be moved—like those in trauma, intensive care, or surgical suites—ensuring imaging can be performed at the patient’s location rather than requiring transfer.

What regulatory pathways has the AMX Navigate followed, and what does the Special 510(k) classification entail?

The AMX Navigate holds FDA 510(k) clearance under a Special 510(k) pathway, classified as Class II, indicating it meets regulatory standards for X-ray imaging systems. The Special 510(k) route typically involves a more detailed review by the FDA’s Radiology (RA) Advisory Committee to demonstrate substantial equivalence to a predicate device. Additionally, it complies with EU MDR (Medical Device Regulation), ensuring alignment with European market requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Medical Systems, LLC

Sources (2)

  • FDA 510(k) K210982 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026