# K052978: GE 1.5T Signa Hde MR System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Nov 9, 2005 after 16 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962061 (1996). 11 ancestors in all.
8 later devices descend from it; 1 cites it directly.
4 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052293: GE 1.5T and 3.0T Signa HDX MR System, Ge Medical Systems, LLC (2005) Summary page 1.

## Most influential descendants
- K103330: Brivo MR355, Optima MR360 (2011), 7 descendants of its own
- K123417: Brivo MR355, Optima MR360 (2013), 5 descendants of its own
- K143251: SIGNA Creator, SIGNA Explorer (2015), 3 descendants of its own
- K211980: SIGNA Prime (2022), 2 descendants of its own
- K223439: SIGNA Victor (2023), 1 descendant of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0609-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Jun 8, 2012 · Class II · Z-1208-2013: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of 
- May 10, 2011 · Class II · Z-0935-2013: An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
- Nov 9, 2010 · Not classified · Z-1427-2011: GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patie
- Oct 6, 2009 · Not classified · Z-0592-2010: GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (

## Indications for use
The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K052978
Methodology: https://510kreport.com/methodology