# K081916: GE Signa MR Oncology Package

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 22, 2008 after 15 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 5 generations back to K962061 (1996). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
4 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052293: GE 1.5T and 3.0T Signa HDX MR System, Ge Medical Systems, LLC (2005) Summary page 1.

## Most influential descendants
- K102155: MR Radiation Oncology Options (2010), 2 descendants of its own
- K123091: Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T (2012), 0 descendants of its own
- K121997: Imris Oncology Package (2012), 0 descendants of its own

## Indications for use
The GE Signa® MR Oncology Package is a patient positioning package intended for use with GE Signa® MR Systems. The Signa® MR Oncology Package when used with a Signa® MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® MR system with Signa® MR Oncology Package 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 vssel and musculaskeletaJ regions of the body. The images produced by the Signa® MR system with Signa ® MR Oncology Package 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 Signa® MR Oncology Package provides an additional patient table for Signa m 0 MR systems that allows patients to be imaged on a flat surface. The flat patient surface enables Signa ® MR systems to acquire images in patient positions similar to other modalities that also utilize a flat patient _iurfarp- uich as X-RAv; rT, PET, and radiation therapy. The Signa ® MR system with Siena ® MR Oncology Packajge may also be used with MR-compatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

Source page: https://510kreport.com/device/K081916
Methodology: https://510kreport.com/methodology