GE Signa Magnetic Resonance Diagnostic Imaging System

• • Terminated Z-0858-06 FDA Unclassified (pre-2012) ·initiated 19 Aug 2005

  During use of GE Signa nuclear magnetic resonance imaging system, a flexible Teflon tube that was part of the magnet vent system ruptured and allowed the magnet to vent into the scan room. Because of helium pressure inside the room, the scan room door could not be reopened after the patient was removed from the scan room.

Full name

GE Signa Magnetic Resonance Diagnostic Imaging Sys

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P830074 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S005

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• What types of medical conditions can the GE Signa MRI system help diagnose, and how does it work to achieve this?

  The GE Signa Magnetic Resonance Diagnostic Imaging System is designed to generate detailed internal images of the human body using strong magnetic fields and radio waves. This technology aids in diagnosing a range of medical conditions, including tumors, vascular diseases, and neurological disorders, by providing high-resolution cross-sectional images of internal structures.

• Is the GE Signa MRI system intended for use in specific clinical settings, and who operates it?

  Yes, the GE Signa MRI system is intended for use exclusively in radiology departments within clinical settings. It is operated by trained radiologic technologists or physicians, who utilize its advanced imaging capabilities to assist in accurate diagnosis.

• How is the GE Signa MRI system supplied, and what maintenance is required to ensure accurate imaging?

  The GE Signa MRI system is supplied as a reusable device, meaning it is not single-use. To ensure accurate imaging, it requires proper maintenance and calibration, which should be performed by trained personnel following manufacturer guidelines.

• What regulatory pathway was followed for the GE Signa MRI system, and what class does it fall under?

  The GE Signa MRI system was authorized through the FDA Premarket Approval (PMA) process, specifically under PMA number P830074. It is classified as a Class II medical device, adhering to regulatory standards for nuclear magnetic resonance imaging systems.

• Are there multiple models or variants of the GE Signa MRI system, and how can I identify them?

  Yes, the GE Signa MRI system includes multiple model variants, each associated with distinct registration numbers (e.g., 3008156140, 3021593788, etc.). These registration numbers help identify specific variants, but the core functionality and regulatory pathway remain consistent across all models.