# K043262: GE Signa Excite MR Surgical Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jan 12, 2005 after 49 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962061 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
4 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System, Ge Medical Systems, LLC (2004) Summary page 1.

## Recalls of this device
- Sep 23, 2015 · Class II · Z-0196-2016: GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. The issue may prevent patient transfer between the MR and surgical tables.
- Dec 15, 2011 · Not classified · Z-1067-2012: GE Healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the OR Compatible patient transfer table of your Optima MR450

## Indications for use
The MR Surgical Option when integrated with the GE Signa® 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution, high signal-to-noise ratio, with short scan times. The Signa® Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial sagittal. coronal and oblique images, spectroscopic images, and/or 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® Excite system with Surgical Option 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. The GE Signa® Excite system with Surgical Option can provide MR images at various stages of a surgical procedure, and provides the capability to transfer a patient to the MR system table directly from a surgical table, or patient transport system. Images can be obtained using the MR scanner body coil, or local surface coils, and the surface coils used with the integrated system mnay / can accommodate sterile draping for surgical procedures.

Source page: https://510kreport.com/device/K043262
Methodology: https://510kreport.com/methodology