# K073425: Modification to Aurora Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Imaging Technology, Inc.
- Decided: Sep 16, 2008 after 288 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 2.
- K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT, GE Medical Systems (1995) Summary page 2.
- K951650: Clinical Proton Spectroscopy Option, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.

## 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, and sagittal cross-sectional images that display the internal structure of 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 (T1), 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 for breast imaging. Anatomical region: Breast tissue, axilla, and chest wall local to the breast Nucleus excited: Proton Diagnostic uses: 2D, 3D T1-/T2-weighted imaging T1, 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 The Aurora MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.

Source page: https://510kreport.com/device/K073425
Methodology: https://510kreport.com/methodology