# K102155: MR Radiation Oncology Options

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 31, 2010 after 32 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: 6 generations back to K962061 (1996). 12 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K081916: GE Signa MR Oncology Package, Ge Medical Systems, LLC (2008) Summary page 1.

## Most influential descendants
- 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 MR Radiation Oncology Options are a patient positioning package intended for use with the GE wide bore MR scanners. The MR Radiation Oncology Options when used with a GE wide bore MR scanner is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The GE wide bore MR scanners with MR Radiation Oncology Options are indicated for use as a diagnostic imaging device to provide 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 vessels, and musculoskeletal regions of the body. The images produced by the GE wide bore scanners with MR Radiation Oncology Options 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 MR Radiation Oncology Options include a removable patient table insert for GE wide bore MR scanners that allow patients to be imaged on a flat surface. The flat patient surface allows image acquisition in patient positions similar to other modalities that also use a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The GE wide bore MR scanners with the MR Radiation Oncology Options 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/K102155
Methodology: https://510kreport.com/methodology