# K023442: Extra Large Body Coil

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Nov 5, 2002 after 21 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 2 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)

## Indications for use
The Signa Ovation (formerly known as MFOA) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation 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 Ovation 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 diagnosis. Due to the ‘open’ design of the system, the Signa Ovation 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/K023442
Methodology: https://510kreport.com/methodology