# K043112: GE 0.2T Signa Profile Excite MR System

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Nov 24, 2004 after 14 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992135 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033168: GE 0.2T Signa Profile/I MR System, General Electric Co. (2003) Summary page 1.

## Recalls of this device
- Jun 8, 2012 · Class II · Z-1209-2013: 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 

## Indications for use
The Signa® Profile EXCITE MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa® Profile EXCITE MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa® Profile EXCITE MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the 'open' design of the system, the Signa® Profile EXCITE MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K043112
Methodology: https://510kreport.com/methodology