# K053009: GE 0.35T Signa Ovation with Excite MR System

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Nov 17, 2005 after 22 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002611 (2000). 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)
- K033504: GE 0.35T Signa Ovation with Excite MR System, General Electric Co. (2003) Summary page 1.

## Recalls of this device
- Nov 15, 2018 · Class II · Z-0693-2019: Possible incorrect software version loaded.
- 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 
- Apr 16, 2009 · Not classified · Z-1556-2009: GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patie
- Nov 3, 2008 · Not classified · Z-1722-2009: GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceilin

## Indications for use
The 0.35T Signa® Ovation with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa 0.35T Signa® Ovation with Excite Magnetic Resonance 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 musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa 0.35T Signa® Ovation with Excite Magnetic Resonance 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 0.35T Signa® Ovation with Excite may also be used 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/K053009
Methodology: https://510kreport.com/methodology