# K032082: Aurora

- Pathway: 510(k) (Special)
- Applicant: Aurora Imaging Technology, Inc.
- Decided: Jul 30, 2003 after 23 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: 1 generation back to K012154 (2001). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012154: Aurora Magnetic Resonance Diagnostic Device, Aurora Imaging Technology, Inc. (2001)

## Most influential descendants
- K073425: Modification to Aurora Mri System (2008), 0 descendants of its own
- K052698: Modification to: Aurora (2005), 0 descendants of its own
- K032678: Modification to: Aurora (2003), 0 descendants of its own

## Indications for use
The AURORA MRI 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 MR 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 MX 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 (Tl), 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/K032082
Methodology: https://510kreport.com/methodology