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GE MR MAX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K912881

by Ge Medical Systems

Identifiers

510(k) Number
K912881 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GE MR MAX is a Nuclear Magnetic Resonance Imaging System, classified as a Class II medical device. It generates detailed images of the internal structures of the body using strong magnetic fields and radio waves, enabling diagnostic evaluation in radiology.

This device is intended for use in clinical settings, including hospitals and diagnostic imaging centers. Supplied as a reusable system, it requires proper maintenance and calibration to ensure MRI safety and image quality. The GE MR MAX operates under FDA 510(k) clearance (K912881) and adheres to regulatory standards outlined in 892.1000, with multiple registration numbers listed for tracking.

Frequently asked questions

What clinical environments is the GE MR MAX designed for and how does its reusable nature impact its use?

The GE MR MAX is designed for clinical settings like hospitals and diagnostic imaging centers, where detailed internal imaging is required. As a reusable system, it requires regular maintenance and calibration to ensure MRI safety and consistent image quality, which is critical in environments where multiple patients are scanned daily. This setup is ideal for high-volume facilities that can dedicate resources to upkeep.

How is the regulatory clearance for the GE MR MAX structured, and what does this mean for buyers or clinicians?

The GE MR MAX holds FDA 510(k) clearance under the classification of a Class II medical device, with the clearance number K912881. This means it has been deemed substantially equivalent to a legally marketed device and adheres to regulatory standards outlined in 892.1000. For buyers or clinicians, this indicates it meets established safety and performance criteria, though ongoing compliance with maintenance protocols remains essential for continued use.

Are there specific registration numbers or tracking identifiers associated with the GE MR MAX, and why might they matter?

Yes, the GE MR MAX is linked to multiple registration numbers (e.g., 3008156140, 3021593788, etc.) for tracking purposes. These identifiers help healthcare facilities manage inventory, ensure compliance with regulatory requirements, and verify the device’s authenticity and maintenance history. They are particularly useful for audits or when reporting to regulatory bodies.

What type of maintenance or calibration is required for the GE MR MAX, and how often should it be performed?

The GE MR MAX, being a reusable MRI system, requires proper maintenance and calibration to ensure MRI safety and image quality. While the exact frequency isn’t specified in the data, such systems typically demand routine checks—often monthly or quarterly—by trained technicians. This includes software updates, hardware inspections, and safety protocol reviews to comply with regulatory standards and avoid downtime.

How does the advisory committee classification (Radiology) for the GE MR MAX influence its use in clinical practice?

The advisory committee classification of Radiology for the GE MR MAX indicates that its development and clearance were reviewed by experts in the field of radiology. This ensures the device aligns with best practices and standards specific to MRI technology, which is critical for accurate diagnostic imaging. Clinicians can rely on this classification to confirm the device’s relevance and reliability for their radiology workflows.

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. Sources consulted: ge medical systems | General Electric

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems

Sources (1)

  • FDA 510(k) K912881 24 fields · synced Oct 6, 2026