# K033504: GE 0.35T Signa Ovation with Excite MR System

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Nov 25, 2003 after 20 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: 1 generation back to K002611 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002611: Signa Mfo/I Magnetic Resonance System, GE Medical Systems (2000)

## Most influential descendants
- K053009: GE 0.35T Signa Ovation with Excite MR System (2005), 0 descendants of its own

## Recalls of this device
- Nov 15, 2018 · Class II · Z-0693-2019: Possible incorrect software version loaded.
- Aug 23, 2010 · Not classified · Z-0426-2011: If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.

## 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 (TI), 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 interventionalprocedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles

Source page: https://510kreport.com/device/K033504
Methodology: https://510kreport.com/methodology