# K032678: Modification to: Aurora

- Pathway: 510(k) (Special)
- Applicant: Aurora Imaging Technology, Inc.
- Decided: Sep 24, 2003 after 26 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: 2 generations back to K012154 (2001). 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)
- K032082: Aurora, Aurora Imaging Technology, Inc. (2003) Summary page 1.

## Indications for use
The AURORX MRJ system is an imaging device. and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The IvIR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR 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 diagnosis determination. The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods. Anatomical region: Breast tissue, axilla, and chest wall local to the breast Nucleus excited: Proton Diagnostic uses: 2D, 3D T1- / T2-weighted imaging TI, T2, proton density measurements Image processing Imaging capabilities: 2D Spin Echo (SE) 2D/3D Gradient Echo (GRE) Fat Suppression Imaging processing: Image Subtraction Image Filtering

Source page: https://510kreport.com/device/K032678
Methodology: https://510kreport.com/methodology